US UK DEUTSCH ESPAÑOL HOME| CONTACT US Search for: PRODUCTS FORWARD HEARTS RESOURCES REPORTING EVENTS ABOUT US Product Notices Customer notification We are pleased to have PMA approval for the HeartSine samaritan PAD family of automated external defibrillators, including the SAM 350P, SAM 360P, and SAM 450P. Stryker has announced discontinued support for the HeartSine samaritan AED, HeartSine samaritan PAD 300 and 300P (SAM 300, SAM 300P) “legacy” public access defibrillators in the United States. FDA event timeline April 2019 – The FDA communicated with all AED manufacturers regarding the final order requiring premarket approval (PMA) applications for new and existing AEDs and necessary AED accessories by February 3, 2020: “In April 2019, the FDA sent letters to all AED manufacturers, who did not submit a premarket approval (PMA) application 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.” * September 2019 – In order to allow customers adequate time to transition to PMA approved AEDs, the FDA updated the deadline for marketing AED accessories to no later than February 3, 2021. “FDA does not intend to enforce compliance with the February 3, 2020, deadline for necessary AED accessories for one year in order to allow health care facilities time to transition to FDA-approved AEDs.” * October 2020 – Due to hardship related to the COVID-19 pandemic the FDA updated their website with a deadline extension for marketing AED accessories to no later than February 3, 2022. *https://www.fda.gov/medical-devices/cardiovascular-devices/automated-external-defibrillators-aeds Stryker’s planned discontinuations October 2020 –The HeartSine samaritan AED was discontinued in 2006 and accessories have not been marketed since 2013. While the Pad-Pak and Pediatric-Pak will continue to be available for use with the SAM 350P, SAM 360P, and SAM 450P devices, the Pad-Pak and Pediatric-Pak are not PMA approved for use with the SAM 300 or SAM 300P; therefore, the Pad-Pak will not be available for use with the SAM 300 or SAM 300P and the Pediatric-Pak will not be available for use with SAM 300P after February 3, 2022. Note this date has been extended from February 3, 2021 to February 3, 2022. Additional resources For more information on this product discontinuation and how we are complying with the latest FDA final order, please review the following. FDA | Automated External Defibrillator (AEDs) Website HeartSine customer letter HeartSine FAQs Thank you for your business and continued partnership. We are committed to providing high-quality, clinically relevant products so that you can be confident in the care you are providing to your communities. Please contact your local Stryker sales representative or authorized distributor to discuss trade-up and flexible financing options to support you during this transition. For more information, review the additional resources above. © 2021 HeartSine Technologies LLC. All Rights Reserved. See Terms, Conditions & Privacy Policy. Home| Products| Forward Hearts| Support| Reporting Events| About Us| Contact Us MANUFACTURER HeartSine Technologies, Ltd. 207 Airport Road West Belfast, BT3 9ED Northern Ireland United Kingdom Tel: +44 28 9093 9400 Fax: +44 28 9093 9401 AUTHORISED REPRESENTATIVE IN THE EUROPEAN COMMUNITY Stryker European Operations Limited Anngrove, IDA Business & Technology Park Carrigtwohill, Co Cork T45HX08 Ireland