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 In this section:

                Cardiovascular Devices

Cardiovascular Devices

                        Medtronic HeartWare Ventricular Assist Device (HVAD) System
          Paclitaxel-Coated Balloons and Stents for Peripheral Arterial Disease
          Automated External Defibrillators (AEDs)


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          Cardiovascular Devices
          Automated External Defibrillators (AEDs)Cardiovascular Devices Automated External Defibrillators (AEDs)
  
  	
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    Print**For Purchasers and Clinical Engineers**

Letter on AEDs and Accessories (PDF)**For Patients and Consumers**

FDA-Approved Devices That Help Keep the Heart Beating
	How AEDs in Public Places Can Restart Hearts

Automated external defibrillators (AEDs) are portable, life-saving devices designed to treat people experiencing sudden cardiac arrest, a medical condition in which the heart stops beating suddenly and unexpectedly.

The combination of CPR and early defibrillation is effective in saving lives when used in the first few minutes following a collapse from sudden cardiac arrest.

On this page

What Are AEDs?
	Check Your AED and AED Accessories: Are They FDA Approved?
	FDA-Approved AEDs
	FDA-Approved AED Accessories
	Important Information for AED and AED Accessory Manufacturers
	The FDA's Continued Efforts to Keep AEDs ReliableWhat Are AEDs?

Automated External Defibrillator (AED) placed on the wall in a public location.
AEDs are a type of computerized defibrillator that automatically analyzes the heart rhythm in people who are experiencing cardiac arrest. When appropriate, it delivers an electrical shock to the heart to restore its normal rhythm. The AED system includes accessories, such as a battery and pad electrodes, that are necessary for the AED to detect and interpret a person's heart rhythm and deliver an electrical shock if one is needed. There are two main types of AEDs: public access and professional use.

**Public access AEDs** can be found in airports, community centers, schools, government buildings, hospitals, and other public locations. They are intended to be used by laypeople who have received minimal training.
	**Professional use AEDs** are used by first responders, such as emergency medical technicians (EMTs) and paramedics, who receive additional AED training.AEDs can be semi-automated or fully automated.

**Semi-automated defibrillators** analyze the heart's rhythm, and if an abnormal heart rhythm is detected that requires a shock, then the device prompts the user to press a button to deliver a defibrillation shock.
	**Fully automated defibrillators**analyze the heart's rhythm and deliver a defibrillation shock if commanded by the device software without user intervention.Check Your AED and AED Accessories: Are They FDA Approved?

There are FDA-approved AEDs and AED accessories available, and we encourage you to ensure your AED and AED accessories are FDA-approved; if they are not, we encourage you to transition to FDA-approved AEDs and AED accessories.

If you or your organization owns an AED system, the FDA recommends you:

Check the tables below to see if your AED system and AED accessories are FDA-approved.
	FDA-Approved AEDs
		FDA-Approved AED Accessories
	Contact the manufacturer of your AED or necessary AED accessories if:
	You are not sure if your AED or AED accessories are FDA-approved or
		They are not FDA-approved and you have not received a letter from the manufacturer.
	Select and purchase necessary AED accessories directly from authorized retailers to help ensure that you are purchasing an FDA-approved device.
	Locate the unique device identifier (UDI) on the AED or AED accessory product labels before you purchase them and consider searching the UDI in the AccessGUDID Database. The Global Unique Device Identification Database (GUDID) lists most medical devices legally sold in the U.S. from manufacturing through distribution to patient use.
	Continue to keep your AED available for use, even if it is not FDA-approved, until you obtain an FDA- approved AED, given the importance of these devices in emergency situations.
	Be aware that if your AED is not FDA-approved, compatible necessary AED accessories may no longer be available to support your AED after February 3, 2022.
	Report problems with AEDs and AED accessories to the FDA by submitting a voluntary report online at MedWatch.FDA-Approved AEDs

The table below lists all AEDs that have received premarket approval from the FDA. If your AED is listed below, no matter your purchase date, the AED is considered FDA-approved. The FDA will update this table when new AEDs are approved. For descriptions of these devices, their indications for use, and related information, follow the Premarket Database links.

Important: If your AED is not listed in this table, please contact the manufacturer of your AED for more information about your device.


Manufacturer
			Device Name
			Approval Date
			Premarket DatabaseAvive Solutions, Inc.
			Avive Automated External Defibrillator (AED) System
			10/31/2022
			P210015Cardiac Science Corporation
			Powerheart G3 AED
			12/07/2018
			P160033Cardiac Science Corporation
			Powerheart G3 Plus AED
			12/07/2018
			P160033Cardiac Science Corporation
			Powerheart G5 AED
			12/07/2018
			P160033Cardiac Science Corporation
			Powerheart G3 PRO AED
			12/06/2018
			P160034Defibtech, LLC
			Lifeline/ReviveR DDU-100
			02/01/2018
			P160032Defibtech, LLC
			Lifeline/ReviveR AUTO DDU-120
			02/01/2018
			P160032Defibtech, LLC
			Lifeline/ReviveR VIEW DDU-2300
			02/01/2018
			P160032Defibtech, LLC
			Lifeline/ReviveR VIEW AUTO DDU-2200
			02/01/2018
			P160032Defibtech, LLC
			Lifeline/ReviveR ECG DDU-2450
			02/01/2018
			P160032Defibtech, LLC
			Lifeline/ReviveR ECG+ DDU-2475
			02/01/2018
			P160032HeartSine Technologies, LLC
			SAM 350P (Samaritan Public Access Automated External Defibrillator)
			01/12/2017
			P160008HeartSine Technologies, LLC
			SAM 360P (Samaritan Public Access Automated External Defibrillator)
			01/12/2017
			P160008HeartSine Technologies, LLC
			SAM 450P (Samaritan Public Access Automated External Defibrillator)
			01/12/2017
			P160008HeartSine Technologies, Ltd.
			samaritan 350P (SAM350P) Automated External Defibrillator
			06/23/2022
			P160008Philips Medical Systems
			HeartStart Home
			06/06/2019
			P160029Philips Medical Systems
			HeartStart OnSite
			06/06/2019
			P160029Philips Medical Systems
			HeartStart FR3
			05/11/2020
			P160028Philips Medical Systems
			HeartStart FRx
			05/11/2020
			P180028Physio-Control, Inc.
			LIFEPAK CR Plus Defibrillator
			12/21/2017
			P160012Physio-Control, Inc.
			LIFEPAK EXPRESS Defibrillator
			12/21/2017
			P160012Physio-Control, Inc.
			LIFEPAK CR2 Defibrillator
			12/21/2018
			P170018Physio-Control, Inc.
			LIFEPAK 15 Monitor/Defibrillator
			07/02/2018
			P160026Physio-Control, Inc.
			LIFEPAK 20E Defibrillator/ Monitor
			07/02/2018
			P160026Physio-Control, Inc.
			LIFEPAK 1000 Defibrillator
			07/02/2018
			P160026ZOLL Medical Corporation
			AED Plus and Fully Automatic AED Plus
			05/26/2017
			P160015ZOLL Medical Corporation
			X Series Defibrillator
			12/27/2017
			P160022ZOLL Medical Corporation
			R Series Defibrillator
			12/27/2017
			P160022ZOLL Medical Corporation
			AED Pro Defibrillator
			12/27/2017
			P160022ZOLL Medical Corporation
			AED 3 BLS Defibrillator
			12/27/2017
			P160022ZOLL Medical Corporation
			Propaq MD Defibrillator
			12/27/2017
			P160022ZOLL Medical Corporation
			AED 3 Defibrillator
			02/28/2020
			P160015/S001

FDA-Approved AED Accessories

The table below lists all necessary AED accessories that have received premarket approval from the FDA and the FDA-approved AED for which it is compatible. The FDA will update this table when new AED accessories are approved.

For more information about the FDA approval of these accessories, their indications for use, and related information, follow the Premarket Database links.

Important: If your AED accessory is not listed in this table, please contact the manufacturer of your accessories for more information about your device.


Manufacturer
			Accessory Name
			Compatible AEDs
			Approval Date
			Premarket DatabaseAED Battery Exchange
			9146-ABE
			Cardiac Science (now ZOLL) Powerheart G3
			02/02/2021
			P190013AED Battery Exchange
			G5-ABE
			Cardiac Science (now ZOLL) Powerheart G5
			02/02/2021
			P190013AED Battery Exchange
			5070-ABE
			Philips HeartStart Onsite/Home (HS1), FRx
			02/02/2021
			P190013AED Battery Exchange
			FR3-ABE
			Philips HeartStart FR3
			02/02/2021
			P190013Avive Solutions, Inc.
			Avive Pad Cartridge
			Avive AED
			10/31/2022
			P210015Cardiac Science (now ZOLL)
			Intellisense Lithium Battery (Model 9146, Model 9147-201-TSO)
			Cardiac Science (now ZOLL) Powerheart G3, G3 Plus
			12/07/2018
			P160033Cardiac Science (now ZOLL)
			Intellisense Defibrillation Pad - Adult (Model 9131)
			Cardiac Science (now ZOLL) Powerheart G3, G3 Plus, G3 Pro
			12/07/2018
			P160033Cardiac Science (now ZOLL)
			Intellisense Defibrillation Pad - Pediatric (Model 9730)
			Cardiac Science (now ZOLL) Powerheart G3, G3 Plus, G3 Pro
			12/07/2018
			P160033Cardiac Science (now ZOLL)
			Intellisense Lithium Battery (ModelXBAED001A, XBTAED005A, XBTAED005A-TSO)
			Cardiac Science (now ZOLL) Powerheart G5
			12/07/2018
			P160033Cardiac Science (now ZOLL)
			Intellisense Defibrillation Pad - Adult (Model XELAED001A, XELAED001B, XELAD001C)
			Cardiac Science (now ZOLL) Powerheart G5
			12/07/2018
			P160033Cardiac Science (now ZOLL)
			Intellisense Defibrillation Pad - Pediatric (Model XELAD003A, XELAD003C)
			Cardiac Science (now ZOLL) Powerheart G5
			12/07/2018
			P160033Cardiac Science (now ZOLL)
			Intellisense Defibrillation Pad - ICPR Adult (Model XELAD002B, XELAED002C)
			Cardiac Science (now ZOLL) Powerheart G5
			12/07/2018
			P160033Cardiac Science (now ZOLL)
			Intellisense Lithium Battery (Model 9145)
			Cardiac Science (now ZOLL) Powerheart G3, G3 Plus, G3 Pro
			12/06/2018
			P160034Cardiac Science (now ZOLL)
			Intellisense Defibrillation Pad - Adult (Model 9131)
			Cardiac Science (now ZOLL) Powerheart G3, G3 Plus, G3 Pro
			12/06/2018
			P160034Cardiac Science (now ZOLL)
			Intellisense Defibrillation Pad - Adult - Polarized (Model 9660)
			Cardiac Science (now ZOLL) Powerheart G3 Pro
			12/06/2018
			P160034Cardiac Science (now ZOLL)
			Intellisense Defibrillation Pad - Pediatric (Model 9730)
			Cardiac Science (now ZOLL) Powerheart G3, G3 Plus, G3 Pro
			12/06/2018
			P160034Cardinal Health
			Kendall 20550 Adult Multi-Function Defibrillation Electrodes
			Physio-Control LIFEPAK 15, 20, 20E, 1000, CR Plus, and Express
			08/07/2020
			P190007Cardinal Health
			Kendall 20770 Adult Multi-Function Defibrillation Electrodes
			ZOLL R Series, X Series, Propaq MD
			08/07/2020
			P190007Cardinal Health
			Medi-Trace 22550A Cadence Adult Multi-Function Defibrillation Electrodes
			Physio-Control LIFEPAK 15, 20, 20E, 1000, CR Plus, and Express
			08/07/2020
			P190007Cardinal Health
			Medi-Trace 22550P Cadence Pediatric Multi-Function Defibrillation Electrodes
			Physio-Control LIFEPAK 15, 20, and 20E
			08/07/2020
			P190007Cardinal Health
			Medi-Trace 22550PC Cadence Adult Multi-Function Defibrillation Electrodes Pre-Connect
			Physio-Control LIFEPAK 15, 20, 20E, 1000, CR Plus, and Express
			08/07/2020
			P190007Cardinal Health
			Medi-Trace 22550R Cadence Adult Multi-Function Defibrillation Electrodes
			Physio-Control LIFEPAK 15, 20, 20E, 1000, CR Plus, and Express
			08/07/2020
			P190007Cardinal Health
			Medi-Trace 22770P Cadence Pediatric Multi-Function Defibrillation Electrodes
			ZOLL R Series, X Series, Propaq MD
			08/07/2020
			P190007Cardinal Health
			Medi-Trace 22770PC Cadence Adult Multi-Function Defibrillation Electrodes Pre-Connect
			ZOLL R Series, X Series, Propaq MD
			08/07/2020
			P190007Cardinal Health
			Medi-Trace 22770R Cadence Adult Multi-Function Defibrillation Electrodes
			ZOLL R Series, X Series, Propaq MD
			08/07/2020
			P190007Cardinal Health
			Kendall 1010P Adult Multi-Function Defibrillation Electrodes
			Physio-Control LIFEPAK 20 and 20E
			08/07/2020
			P190007Cardinal Health
			Kendall 1310P Adult Multi-Function Defibrillation Electrodes
			Physio-Control LIFPEAK 15, 20, 20E, 1000, CR Plus, and Express
			08/07/2020
			P190007Cardinal Health
			Kendall 1410 Adult Multi-Function Defibrillation Electrodes
			ZOLL R Series, X Series, Propaq MD
			08/07/2020
			P190007Cardinal Health
			QUIK-COMBO Radiotransparent Physio-Control Defibrillation Electrode
			Physio-Control LIFEPAK 15, 20, and 20E
			08/07/2020
			P190007Cardinal Health
			QUIK-COMBO Physio-Control Defibrillation Electrode
			Physio-Control LIFEPAK 15, 20, and 20E
			08/07/2020
			P190007Cardinal Health
			QUIK-COMBO Redi-Pak Preconnect Medtronic Defibrillation Electrode
			Physio-Control LIFEPAK 15, 20, 20E, 1000, CR Plus, and Express
			08/07/2020
			P190007Cardinal Health
			QUIK-COMBO RTS Pediatric Defibrillation Electrode
			Physio-Control LIFEPAK 15, 20, and 20E
			08/07/2020
			P190007Conmed
			Adult/Child 2001 (radiotransparent) and 2516 (radiotranslucent)
			Physio-Control LIFEPAK 15, 20, and 20E; ZOLL R Series, X Series, Propaq MD
			09/26/2021
			P200004Conmed
			Adult/Child Model 2502 (Sterile)
			Physio-Control LIFEPAK 15, 20, and 20E; ZOLL R Series, X Series, Propaq MD
			09/26/2021
			P200004Conmed
			Infant Model 2603 and Mini-Infant Model 2602
			Physio-Control LIFEPAK 15, 20, and 20 E; ZOLL R Series, X Series, Propaq MD
			09/26/2021
			P200004Conmed
			PadPro Multi-Function Electrode Adaptors (ZMUF, ZMMF)
			ZOLL R Series, X Series, Propaq MD
			09/26/2021
			P200004Conmed
			PadPro Multi-Function Electrode Adaptors (MMUF, MMZF)
			Physio-Control LIFEPAK 15, 20, and 20E
			09/26/2021
			P200004Defibtech
			DDP-100 Adult Defibrillation Pads
			Defibtech Lifeline/ReviveR DDU-100, AUTO DDU-120
			06/10/2021
			P160032/S005Defibtech
			DDP-200P Pediatric Defibrillation Pads
			Defibtech Lifeline/ReviveR DDU-100, AUTO DDU-120
			06/10/2021
			P160032/S005Defibtech
			DBP-1400 5 year non-rechargeable battery pack
			Defibtech Lifeline/ReviveR DDU-100, AUTO DDU-120
			06/10/2021
			P160032/S005Defibtech
			DBP-2800 7 year non-rechargeable battery pack
			Defibtech Lifeline/ReviveR DDU-100, AUTO DDU-120
			06/10/2021
			P160032/S005Defibtech
			DDP-2001 Adult Defibrillation Pads
			Defibtech Lifeline/ReviveR VIEW DDU-2300, VIEW AUTO DDU-2200, ECG DDU-2450, ECG+ DDU-2475
			06/10/2021
			P160032/S005Defibtech
			DDP-2002 Pediatric Defibrillation Pads
			Defibtech Lifeline/ReviveR VIEW DDU-2300, VIEW AUTO DDU-2200, ECG DDU-2450, ECG+ DDU-2475
			06/10/2021
			P160032/S005Defibtech
			DBP-2003 4 year non-rechargeable battery pack
			Defibtech Lifeline/ReviveR VIEW DDU-2300, VIEW AUTO DDU-2200, ECG DDU-2450, ECG+ DDU-2475
			06/10/2021
			P160032/S005Defibtech
			DBP-2013 4 year non-rechargeable TSO battery pack
			Defibtech Lifeline/ReviveR VIEW DDU-2300, VIEW AUTO DDU-2200, ECG DDU-2450, ECG+ DDU-2475
			06/10/2021
			P160032/S005HeartSine
			Pad-Pak-01 (Adult)
			HeartSine samaritan PAD 350P, 360P, and 450P
			01/12/2017
			P160008HeartSine
			Pad-Pak-02 (Pediatric)
			HeartSine samaritan PAD 350P, 360P, and 450P
			01/12/2017
			P160008HeartSine
			Pad-Pak-7 (Aviation/TSO)
			HeartSine samaritan PAD 350P, 360P, and 450P
			01/12/2017
			P160008Philips
			Primary Battery (Model M5070A)
			Philips HeartStart Onsite/Home (HS1), FRx
			06/06/2019
			P160029Philips
			SMART Pads Cartridges (Adult Model M5071A)
			Philips HeartStart Onsite/Home (HS1)
			06/06/2019
			P160029Philips
			SMART Pads Cartridges (Pediatric Model M5072A)
			Philips HeartStart Onsite/Home (HS1)
			06/06/2019
			P160029Philips
			Primary Battery (Models 989803150161, 989803150171)
			Philips HeartStart FR3
			05/11/2020
			P160028Philips
			Rechargeable Battery (Model 989803150241)
			Philips HeartStart FR3
			05/11/2020
			P160028Philips
			Charger for the Rechargeable Battery (Model 861394)
			Philips HeartStart FR3
			05/11/2020
			P160028Philips
			SmartPads III (Models 989803149981, 989803149991)
			Philips HeartStart FR3
			05/11/2020
			P160028Philips
			Pediatric Key (Model 989803150031)
			Philips HeartStart FR3
			05/11/2020
			P160028Philips
			Primary Battery (M5070A)
			Philips HeartStart Onsite/Home (HS1), FRx
			05/11/2020
			P180028Philips
			Aviation FRx Battery (989803139301)
			Philips HeartStart FRx
			05/11/2020
			P180028Philips
			SMART Pads II (989803139261)
			Philips HeartStart FRx
			05/11/2020
			P180028Philips
			Infant/Child Key (989803139311)
			Philips HeartStart FRx
			05/11/2020
			P180028Physio-Control
			CHARGE-PAK Battery Charger
			Physio-Control LIFEPAK CR Plus and Express
			12/21/2017
			P160012Physio-Control
			QUICK-STEP Pacing/ECG Defibrillation Electrodes
			Physio-Control LIFEPAK CR2
			12/21/2018
			P170018Physio-Control
			LIFEPAK CR2 Lithium Battery
			Physio-Control LIFEPAK CR2
			12/21/2018
			P170018Physio-Control
			LIFEPAK 1000 Defibrillator Lithium-Ion Rechargeable Battery
			Physio-Control LIFEPAK 1000
			07/02/2018
			P160026Physio-Control
			LIFEPAK 1000 Defibrillator Non-Rechargeable Battery
			Physio-Control LIFEPAK 1000
			07/02/2018
			P160026Physio-Control
			LIFEPAK Lithium-ion Rechargeable Battery
			Physio-Control LIFEPAK 15
			07/02/2018
			P160026Physio-Control
			QUIK-COMBO Therapy Cable - Lifepak 20e
			Physio-Control LIFEPAK 20e
			07/02/2018
			P160026Physio-Control
			QUIK-COMBO Therapy Cable - Lifepak 15
			Physio-Control LIFEPAK 15
			07/02/2018
			P160026Physio-Control
			QUIK-PAK Electrodes
			Physio-Control LIFEPAK CR Plus and Express
			11/29/2021
			P160012/S002Physio-Control
			Infant/Child Reduced Energy Defibrillation Electrodes
			Physio-Control LIFEPAK 1000, CR Plus, and Express
			07/08/2021
			P160012/S003 (bundled)Physio-Control
			Infant/Child Reduced Energy Defibrillation Electrodes
			Physio-Control LIFEPAK 1000, CR Plus, and Express
			07/08/2021
			P160026/S015 (bundled)ZOLL
			CPR-D-Padz Electrode
			ZOLL AED Plus, AED 3
			05/26/2017
			P160015ZOLL
			CPR Stat-Padz Electrode
			ZOLL AED Plus, AED 3
			05/26/2017
			P160015ZOLL
			Stat-Padz II Electrode
			ZOLL AED Plus, AED 3
			05/26/2017
			P160015ZOLL
			Pedi-Padz II Electrode
			ZOLL AED Plus, AED 3
			05/26/2017
			P160015ZOLL
			AED Plus Aviation Battery Assembly
			ZOLL AED Plus
			05/26/2017
			P160015ZOLL
			Pro-Padz Radiotransparent Electrode
			ZOLL R Series, X Series
			12/27/2017
			P160022ZOLL
			SurePower Battery Pack
			ZOLL R Series, AED Pro
			12/27/2017
			P160022ZOLL
			SurePower II Battery Pack
			ZOLL X Series, Propaq MD
			12/27/2017
			P160022ZOLL
			AED Pro Non-Rechargeable Lithium Battery Pack
			ZOLL AED Pro
			12/27/2017
			P160022ZOLL
			AED 3 Battery Pack
			ZOLL AED 3, AED 3 BLS
			12/27/2017
			P160022ZOLL
			SurePower Charger
			ZOLL R Series, X Series, Propaq MD, AED Pro
			12/27/2017
			P160022ZOLL
			SurePower Single Bay Charger
			ZOLL R Series, X Series, Propaq MD, AED Pro
			12/27/2017
			P160022ZOLL
			CPR Uni-Padz electrode
			ZOLL AED 3, AED Plus
			02/28/2020
			P160015/S001ZOLL
			AED 3 Battery Pack
			ZOLL AED 3, AED 3 BLS
			02/28/2020
			P160015/S001Graphic Controls d.b.a. Nissha Medical Technologies, Vermed, Biomedical Innovations
			HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads
			Physio-Control LIFEPAK 15, 20/20e, and 1000; ZOLL R-Series, X-Series; Cardiac Science (now ZOLL) PowerHeart AED G3 Plus, G3 Pro
			06/23/2023
			P200007ZOLL
			Pro-padz Sterile Electrodes
			X Series, Propaq MD, R Series
			12/20/2022
			P160022/S014ZOLL
			Stat-padz Electrodes
			X Series, Propaq MD, R Series,
			12/20/2022
			P160022/S014ZOLL
			Stat-padz Deployment Readiness Pack Electrodes
			X Series, Propaq MD, R Series
			12/20/2022
			P160022/S014ZOLL
			Pedi-padz Electrodes
			X Series, Propaq MD, R Series
			12/20/2022
			P160022/S014ZOLL
			Pedi-padz II Electrodes
			X Series, Propaq MD, R Series, AED Pro, AED 3 BLS, AED Plus
			12/20/2022
			P160022/S014ZOLL
			Stat-padz II Electrodes
			X Series, Propaq MD, R Series, AED Pro, AED 3 BLS, AED Plus
			12/20/2022
			P160022/S014ZOLL
			OneStep CPR Cable
			R Series
			12/20/2022
			P160022/S014ZOLL
			X Series/Propaq MD Multifunction Therapy Cable
			X Series, Propaq MD
			12/20/2022
			P160022/S014ZOLL
			X Series OneStep Cable
			X Series, Propaq MD
			12/20/2022
			P160022/S014ZOLL
			Multifunction Therapy Cable with CPR-D Connector
			X Series, Propaq MD
			12/20/2022
			P160022/S014ZOLL
			OneStep CPR Complete Electrodes
			X Series, Propaq MD, R Series
			06/21/2023
			P160022/S015ZOLL
			OneStep CPR Complete Adult-Child Electrodes
			X Series, Propaq MD, R Series
			06/21/2023
			P160022/S015ZOLL
			OneStep Basic Electrodes
			X Series, Propaq MD, R Series
			06/21/2023
			P160022/S015ZOLL
			OneStep Pacing Electrodes
			X Series, Propaq MD, R Series
			06/21/2023
			P160022/S015ZOLL
			OneStep Pediatric Electrodes
			X Series, Propaq MD, R Series
			06/21/2023
			P160022/S015ZOLL
			OneStep Pediatric CPR Electrodes
			X Series, Propaq MD, R Series
			06/21/2023
			P160022/S015ZOLL
			OneStep CPR II Electrodes
			R Series
			06/21/2023
			P160022/S015ZOLL
			OneStep CPR A/A (Anterior/Anterior) Electrodes
			X Series, Propaq MD, R Series
			06/21/2023
			P160022/S015ZOLL
			OneStep CPR Electrodes
			X Series, Propaq MD, R Series
			06/21/2023
			P160022/S015ZOLL
			X Series OneStep Cable
			X Series, Propaq MD
			06/21/2023
			P160022/S015ZOLL
			OneStep CPR Cable
			R Series
			06/21/2023
			P160022/S015ZOLL
			R Series OneStep Pacing Cable
			R Series
			06/21/2023
			P160022/S015ZOLL
			X Series/Propaq MD Multifunction Therapy Cable
			X Series, Propaq MD
			06/21/2023
			P160022/S015ZOLL
			Pedi-padz Liquid Gel Electrodes
			X Series, Propaq MD, R Series
			12/19/2022
			P160022/S016ZOLL
			Adult Liquid Gel Electrodes
			X Series, Propaq MD, R Series
			12/19/2022
			P160022/S016ZOLL
			Pro-padz Radiolucent Liquid Gel Electrodes
			X Series, Propaq MD, R Series
			12/19/2022
			P160022/S016ZOLL
			Pro-padz Radiolucent Electrodes
			X Series, Propaq MD, R Series
			12/19/2022
			P160022/S016ZOLL
			Pedi-padz Radiolucent Electrodes
			X Series, Propaq MD, R Series
			12/19/2022
			P160022/S016ZOLL
			CPR-D-padz Electrodes
			X Series, Propaq MD, R Series, AED Pro, AED 3 BLS, AED Plus
			12/19/2022
			P160022/S016ZOLL
			CPR Stat-padz Electrodes
			X Series, Propaq MD, R Series, AED Pro, AED 3 BLS, AED Plus
			12/19/2022
			P160022/S016ZOLL
			CPR Dura-padz Reusable Electrodes
			X Series, Propaq MD, R Series, AED Pro
			12/19/2022
			P160022/S016ZOLL
			OneStep Cable
			R Series
			12/19/2022
			P160022/S016ZOLL
			OneStep Pacing Cable
			R Series
			12/19/2022
			P160022/S016ZOLL
			R Series MFC (Multifunction Cable)
			R Series
			12/19/2022
			P160022/S016ZOLL
			Multifunction Therapy Cable CPRD Adapter (MFC to CPRD Connector)
			R Series
			12/19/2022
			P160022/S016ZOLL
			CPR Connector
			X Series, Propaq MD
			12/19/2022
			P160022/S016

Important Information for AED and AED Accessory Manufacturers

To ensure the quality and reliability of AEDs, the FDA requires manufacturers to obtain premarket approval for all AEDs and AED accessories.

The FDA expects that necessary AED accessories will be labeled for use with an FDA-approved AED device (on the list above). Manufacturers submitting a premarket approval application (PMA) for necessary AED accessories should be aware that they can continue to market those accessories while the PMA is pending until the FDA issues a decision (approval, not approvable, or denial decision). After a PMA decision is made, only FDA-approved accessories can continue to be marketed.

The FDA's premarket approval of new and existing AEDs and AED accessories is based on a determination that the application contains sufficient valid scientific evidence to reasonably assure the device is safe and effective for its intended use. This regulatory pathway requires manufacturers to receive FDA approval before initiating design, manufacturing, or labeling changes to the device, and imposes certain annual reporting requirements.

Once the AEDs and AED accessories are on the market, the FDA proactively monitors their safety and reliability by reviewing the manufacturers' manufacturing and design changes, performance reports, and medical device reports (MDRs). When a company initiates a correction or removal action, the FDA posts information about the action in the public Medical Device Recall database. Once classified, the FDA monitors the recall to ensure the recall strategy has been effective.

The FDA's Continued Efforts to Keep AEDs Reliable

The FDA recognizes the importance of AEDs as life-saving devices. Problems associated with AEDs include design and manufacturing issues, such as inadequate control of components purchased from suppliers or inadequate validation of manufacturing processes. When this occurs, an AED can malfunction and may contribute to patient harm or prevent the rescue of the patient.

Given this, the FDA has taken several actions to assure that current and future AEDs and necessary accessories are safe and reliable. These actions include:

**November 2022:** The FDA sent letters to AED accessory manufacturers who did not submit a PMA for their AED accessories as required by the final order reminding them that they can no longer market their AED accessories.
	**By February 3, 2022:** Manufacturers of previously-cleared necessary accessories (such as batteries, pad electrodes, adapters) for the operation of AED systems that are FDA-approved were required to file a premarket approval application (PMA).
	**October 27, 2020:** FDA revised its compliance policy regarding the deadline for filing a PMA for previously-cleared necessary AED accessories until February 3, 2022. This revised compliance policy allowed health care facilities and manufacturers to remain focused on public health needs related to the COVID-19 public health emergency, while allowing time to transition to FDA-approved AEDs.
	**By February 3, 2020:** Original date manufacturers of previously-cleared necessary accessories (such as batteries, pad electrodes, adapters) for AED systems that are FDA-approved were to file a PMA.
	**April 2019:**The FDA sent letters to all AED manufacturers, who did not submit a PMA for their AEDs as required by the final order, reminding them they can no longer market their AED; the letters also informed the manufactures that necessary AED accessories may not be marketed after February 3, 2020, if a PMA is not filed. Manufacturers were asked to provide a plan for these AEDs and necessary AED accessories, including a timeline for servicing and phase-out activities, a plan for communicating with their customers, and an estimate of the volume of AEDs and accessories that remain in the field.
	**November 1, 2017:** The FDA and Philips Medical Systems LLC entered a consent decreeof permanent injunction prohibiting Philips Medical Systems, Philips Healthcare, and those individually named from manufacturing, processing, packing, holding, or distributing AEDs from two facilities until they comply with the Federal Food, Drug, and Cosmetic Act (FD&C Act).
	**February 2015:** The FDA published a final order in February 2015 requiring premarket approval (PMA) applications for new and existing AEDs and necessary AED accessories.
	**December 2013:** The FDA issued a Safety Communication alerting all users of the Philips HeartStart FRx, HS1 Home and HS1 OnSite AEDs manufactured between 2005 and 2012 that these devices may fail to deliver a shock in the event of an emergency.
	**March 2013:**The FDA published a proposed orderto allow for notice and comment regarding the FDA's recommendation to require premarket approval (PMA) applications for AEDs and necessary AED accessories.
	**January 2011:** The FDA convened a public meetingof the Circulatory System Device Panel of the Medical Devices Advisory Committee where the FDA presented its comprehensive assessment of AEDs. The panel of independent experts considered the FDA's assessment of AEDs and its recommendation that more stringent FDA oversight be applied to reduce future AED problems. The panel agreed with the FDA's recommendation to require PMA applications for AEDs.

                                                                                  Content current as of:
      07/06/2023
              
              
Regulated Product(s)
		 Medical Devices
			  			     			  						              
			
			
			
			
			
			
			  
			  CardiovascularCardiovascular Devices

          
                        Medtronic HeartWare Ventricular Assist Device (HVAD) System
          Paclitaxel-Coated Balloons and Stents for Peripheral Arterial Disease
          Automated External Defibrillators (AEDs)


                        What is a Heater-Cooler Device?
 
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