Document ID: FDA-2021-M-0153-0002
Agency: fda
Document Type: Notice
Title: Medical Devices: Safety and Effectiveness Summaries for Premarket Approval Applications
Posted Date: 2022-06-08T04:00Z

[Federal Register Volume 87, Number 110 (Wednesday, June 8, 2022)]
[Notices]
[Pages 34884-34887]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-12371]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2021-M-0228, FDA-2021-M-0202, FDA-2021-M-0203, FDA-
2021-M-0178, FDA-2021-M-0153, FDA-2021-M-0135, FDA-2021-M-0325, FDA-
2021-M-0303, FDA-2021-M-0288, FDA-2021-M-0421, FDA-2021-M-0416, FDA-
2021-M-0355, FDA-2021-M-0354, FDA-2021-M-0520, FDA-2021-M-0615, FDA-
2021-M-0531, FDA-2021-M-0527, FDA-2021-M-0820, FDA-2021-M-0769, FDA-
2021-M-0766, FDA-2021-M-0676, FDA-2021-M-0690, FDA-2021-M-0656, FDA-
2021-M-0494, FDA-2021-M-0915, FDA-2021-M-0911, FDA-2021-M-0853, FDA-
2021-M-0805, FDA-2021-M-1046, FDA-2021-M-1010, FDA-2021-M-0991, FDA-
2021-M-0989, FDA-2021-M-0975, FDA-2021-M-0962, FDA-2021-M-1176, FDA-
2021-M-1119, FDA-2021-M-1116, FDA-2021-M-0532, FDA-2021-M-1058, FDA-
2021-M-1182, FDA-2021-M-1023, FDA-2021-M-1207, FDA-2021-M-1284, FDA-
2021-M-1271, FDA-2021-M-1317, FDA-2021-M-1321, FDA-2021-M-1316, FDA-
2021-M-1325, FDA-2021-M-1352, FDA-2022-M-0029, FDA-2022-M-0071, FDA-
2022-M-0087, FDA-2022-M-0089, FDA-2022-M-0090, and FDA-2022-M-0171].

Medical Devices; Availability of Safety and Effectiveness 
Summaries for Premarket Approval Applications

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is publishing 
a list of premarket approval applications (PMAs) that have been 
approved from January 1, 2021, through February 14, 2022. This list is 
intended to inform the public of the availability of safety and 
effectiveness summaries of approved PMAs through the internet and the 
Agency's Dockets Management Staff. This is the last notice of this kind 
considering FDA's rule discontinuing the practice of publishing such 
summaries in the Federal Register. As indicated in that rule, FDA will 
continue to publish to make available on the internet and place on 
public display summaries of safety and effectiveness for approved PMAs.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on https://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand Delivery/Courier (for written/paper 
submissions): Dockets Management Staff (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Dockets 
Management Staff, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos. 
FDA-2021-M-0228, FDA-2021-M-0202, FDA-2021-M-0203, FDA-2021-M-0178, 
FDA-2021-M-0153, FDA-2021-M-0135, FDA-2021-M-0325, FDA-2021-M-0303, 
FDA-2021-M-0288, FDA-2021-M-0421, FDA-2021-M-0416, FDA-2021-M-0355, 
FDA-2021-M-0354, FDA-2021-M-0520, FDA-2021-M-0615, FDA-2021-M-0531, 
FDA-2021-M-0527, FDA-2021-M-0820, FDA-2021-M-0769, FDA-2021-M-0766, 
FDA-2021-M-0676, FDA-

[[Page 34885]]

2021-M-0690, FDA-2021-M-0656, FDA-2021-M-0494, FDA-2021-M-0915, FDA-
2021-M-0911, FDA-2021-M-0853, FDA-2021-M-0805, FDA-2021-M-1046, FDA-
2021-M-1010, FDA-2021-M-0991, FDA-2021-M-0989, FDA-2021-M-0975, FDA-
2021-M-0962, FDA-2021-M-1176, FDA-2021-M-1119, FDA-2021-M-1116, FDA-
2021-M-0532, FDA-2021-M-1058, FDA-2021-M-1182, and FDA-2021-M-1023, 
FDA-2021-M-1207, FDA-2021-M-1284, FDA-2021-M-1271, FDA-2021-M-1317, 
FDA-2021-M-1321, FDA-2021-M-1316, FDA-2021-M-1325, FDA-2021-M-1352, 
FDA-2022-M-0029, FDA-2022-M-0071, FDA-2022-M-0087, FDA-2022-M-0089, 
FDA-2022-M-0090, and FDA-2022-M-0171 for ``Medical Devices; 
Availability of Safety and Effectiveness Summaries for Premarket 
Approval Applications.'' Received comments will be placed in the docket 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at https://www.regulations.gov or at the Dockets 
Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-
402-7500.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on https://www.regulations.gov. 
Submit both copies to the Dockets Management Staff. If you do not wish 
your name and contact information to be made publicly available, you 
can provide this information on the cover sheet and not in the body of 
your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Dharmesh Patel, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 2434, Silver Spring, MD 20993-0002, 301-796-3289, 
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

    In accordance with section 515(d)(4) and (e)(2) of the Federal 
Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 360e(d)(4) and 
(e)(2)), notification of an order approving, denying, or withdrawing 
approval of a PMA will continue to include a notice of opportunity to 
request review of the order under section 515(g) of the FD&C Act. The 
30-day period for requesting reconsideration of an FDA action under 
Sec.  10.33(b) (21 CFR 10.33(b)) for notices announcing approval of a 
PMA begins on the day the notice is published in the Federal Register. 
Section 10.33(b) provides that FDA may, for good cause, extend this 30-
day period. Reconsideration of a denial or withdrawal of approval of a 
PMA may be sought only by the applicant; in these cases, the 30-day 
period will begin when the applicant is notified by FDA in writing of 
its decision.
    Prior to February 14, 2022, the regulations provided that FDA 
publish a list of available safety and effectiveness summaries of PMA 
approvals and denials that were announced in the Federal Register. FDA 
issued a rule discontinuing this practice on January 13, 2022 (87 FR 
2042). At that time, FDA committed to continue to publish lists of 
safety and effectiveness summaries of PMA approvals and denials on its 
website. The following list of approved PMAs for which summaries of 
safety and effectiveness that were placed on the internet from January 
1, 2021, through February 14, 2022, will, therefore, be our last such 
list to be published in this manner. There were no denial actions 
during this period. The list in table 1 provides the manufacturer's 
name, the product's generic name or trade name, and the approval date.

 Table 1--List of Safety and Effectiveness Summaries for Approved PMAs and Safety and Probable Benefit Summaries
                for Approved HDEs Made Available From January 1, 2021, Through February 14, 2022
----------------------------------------------------------------------------------------------------------------
                                                                                                       Approval
           PMA No., docket No.                     Applicant                    Trade name               date
----------------------------------------------------------------------------------------------------------------
P200003, FDA-2021-M-0070................  Seno Medical Instruments,   Imagio[supreg] Breast Imaging      1/11/21
                                           Inc.                        System.
P200028, FDA-2021-M-0135................  Medtronic, Inc............  DiamondTempTM Ablation System    1/28/2021
                                                                       consisting of DiamondTempTM
                                                                       AblaDiamondTemp Ablation
                                                                       Catheter (Models CEDT100S,
                                                                       CEDT200L, CEDTB300S,
                                                                       CEDTB400L); DiamondTempTM RF
                                                                       Generator (Model CEDTG200);
                                                                       DiamondTempTM Irrigation
                                                                       Pump (Model CEDTP100);
                                                                       DiamondTempTM Irrigation
                                                                       Tubing Set (Model
                                                                       CEDTTS100); DiamondTempTM
                                                                       Catheter-to-RF Generator
                                                                       Cable (Model CEDTC100);
                                                                       DiamondTempTM GenConnect
                                                                       Cable (Model CEDTGC100);
                                                                       DiamondTempTM EGM Cable
                                                                       (Model CEDTEGM100).
P140029/S027, FDA-2021-M-0153...........  Q-Med AB..................  Restylane[supreg] Defyne.....    1/29/2021
P190005, FDA-2021-M-0178................  Roche Diagnostics.........  Elecsys Anti-HBe,                 2/3/2021
                                                                       PreciControl Anti-HBe.
P200039, FDA-2021-M-0202................  Shockwave Medical, Inc....  Shockwave Intravascular          2/12/2021
                                                                       Lithotripsy (IVL) System
                                                                       with the Shockwave C\2\
                                                                       Coronary Intravascular
                                                                       Lithotripsy (IVL) Catheter.
P190013, FDA-2021-M-0288................  AED Battery Exchange, LLC.  AED Battery Exchange (Models     2/13/2021
                                                                       9146-ABE, G5-ABE, 5070-ABE,
                                                                       FR3-ABE).

[[Page 34886]]

 
H200001, FDA-2021-M-0203................  Additive Orthopaedics, LLC  Patient Specific Talus Spacer    2/17/2021
P190034, FDA-2021-M-0228................  Roche Diagnostics.........  Elecsys Anti-HBs II,             2/23/2021
                                                                       PreciControl Anti-HBs, Anti-
                                                                       HBs CalCheck.
P200029, FDA-2021-M-0303................  Boston Scientific           TheraSphereTM................    3/17/2021
                                           Corporation.
P200025, FDA-2021-M-0325................  Bausch Health.............  ClearVisc Ophthalmic             3/23/2021
                                                                       Viscosurgical Device (OVD).
P200046, FDA-2021-M-0354................  Medtronic, Inc............  Medtronic Harmony                3/26/2021
                                                                       Transcatheter Pulmonary
                                                                       Valve (TPV) System.
P200022/S003, FDA-2021-M-0355...........  Simplify Medical, Inc.....  Simplify[supreg] Cervical         4/1/2021
                                                                       Artificial Disc.
P200019, FDA-2021-M-0416................  Ventana Medical Systems,    VENTANA MMR RxDx Panel.......    4/22/2021
                                           Inc.
P980040/S124, FDA-2021-M-0421...........  Johnson & Johnson Surgical  TECNIS SynergyTM IOL, Model      4/28/2021
                                           Vision, Inc.                ZFR00V, TECNIS SynergyTM
                                                                       Toric II IOL, Models ZFW150,
                                                                       ZFW225, ZFW300, ZFW375,
                                                                       TECNIS SynergyTM IOL with
                                                                       TECNIS SimplicityTM Delivery
                                                                       System, Model DFR00V, TECNIS
                                                                       SynergyTM Toric II IOL with
                                                                       TECNIS SimplicityTM Delivery
                                                                       System, Model DFW150,
                                                                       DFW225, DFW300, DFW375.
P200002, FDA-2021-M-0418................  AtriCure, Inc.............  EPi-Sense[supreg] Guided           4/28/21
                                                                       Coagulation System.
P140031/S125, FDA-2021-M-0473...........  Edwards Lifesciences, LLC.  Edwards SAPIEN 3 and SAPIEN 3      5/13/21
                                                                       Ultra Transcatheter Heart
                                                                       Valve System.
P200010/S001, FDA-2021-M-0520...........  Guardant Health, Inc......  Guardant360 CDx..............    5/21/2021
P110027/S012, FDA-2021-M-0531...........  QIAGEN GmbH...............  therascreen[supreg] KRAS RGQ     5/28/2021
                                                                       PCR Kit.
P110033/S053, FDA-2021-M-0527...........  Allergan..................  JUV[Eacute]DERM[supreg]          5/28/2021
                                                                       VOLBELLA[supreg] XC.
P200010/S002, FDA-2021-M-0494...........  Guardant Health, Inc......  Guardant360 CDx..............    5/28/2021
P100010/S110, FDA-2021-M-0690...........  Medtronic, Inc............  Arctic Front AdvanceTM           6/18/2021
                                                                       Cardiac Cryoablation
                                                                       Catheters, Arctic Front
                                                                       Advance ProTM Cardiac
                                                                       Cryoablation Catheters,
                                                                       FreezorTM MAX Cardiac
                                                                       Cryoablation Catheter,
                                                                       CryoConsole Manual
                                                                       Retraction Kit.
P200021, FDA-2021-M-0615................  Oticon Medical............  Neuro Cochlear Implant System    6/23/2021
P110019/S115, FDA-2021-M-0656...........  Abbott Vascular...........  XIENCE Alpine Everolimus         6/25/2021
                                                                       Eluting Coronary Stent
                                                                       Systems (XIENCE Alpine
                                                                       EECSS), XIENCE Sierra
                                                                       Everolimus Eluting Coronary
                                                                       Stent Systems (XIENCE Sierra
                                                                       EECSS), and the XIENCE
                                                                       Skypoint Everolimus Eluting
                                                                       Coronary Stent Systems
                                                                       (XIENCE Skypoint EECSS).
P140029/S032, FDA-2021-M-0676...........  Q-Med AB, a Galderma        Restylane[supreg] Contour....    6/28/2021
                                           affiliate.
P200017, FDA-2021-M-0766................  Siemens Healthcare          ADVIA Centaur[supreg] Anti-      7/14/2021
                                           Diagnostics Inc.            HBe2 (aHBe2) assay.
P190032/S001, FDA-2021-M-0707...........  Foundation Medical, Inc...  FoundationOne[supreg] Liquid       7/15/21
                                                                       CDx (F1 Liquid).
P130022/S039, FDA-2021-M-0769...........  Nervo Corporation.........  Senza[supreg] Spinal Cord        7/16/2021
                                                                       Stimulation (SCS) System.
P200037, FDA-2021-M-0820................  Kestra Medical              ASSURE[supreg] Wearable          7/27/2021
                                           Technologies, Inc.          Cardioverter Defibrillator
                                                                       (WCD) System (ASSURE System).
P200011, FDA-2021-M-0853................  Pillar Biosciences, Inc...  ONCO/RevealTM Dx Lung & Colon    7/30/2021
                                                                       Cancer Assay.
P200045, FDA-2021-M-0805................  Bolton Medical, Inc.......  RelayPro Thoracic Stent-Graft     8/5/2021
                                                                       System.
P200049, FDA-2021-M-0911................  Abbott Medical............  AmplatzerTM AmuletTM Left        8/14/2021
                                                                       Atrial Appendage Occluder.
P210001, FDA-2021-M-0915................  Ventana Medical Systems,    VENTANA MMR RxDx Panel.......    8/17/2021
                                           Inc.
P160045/S028, FDA-2021-M-0962...........  Life Technologies           Oncomine[supreg] Dx Target       8/25/2021
                                           Corporation.                Test.
P210007, FDA-2021-M-0991................  MicroTransponder Inc......  MicroTransponder[supreg]         8/27/2021
                                                                       Vivistim[supreg] Paired
                                                                       VNSTM System
                                                                       (Vivistim[supreg] System).
P050052/S129, FDA-2021-M-0975...........  Merz North America, Inc...  RADIESSE[supreg] (+)              9/1/2021
                                                                       Lidocaine injectable implant.
P180051, FDA-2021-M-0989................  TransMedics, Inc..........  Organ Care System (OCSTM)         9/3/2021
                                                                       Heart System.
P160045/S029, FDA-2021-M-1023...........  Life Technologies           OncomineTM Dx Target Test....    9/15/2021
                                           Corporation.
P190023, FDA-2021-M-1010................  Abbott Medical............  PorticoTM Transcatheter          9/17/2021
                                                                       Aortic Valve Implantation
                                                                       System: PorticoTM
                                                                       Transcatheter Aortic Heart
                                                                       Valve, FlexNavTM Delivery
                                                                       System, FlexNavTM Loading
                                                                       System.
P200004, FDA-2021-M-1046................  ConMed Corporation........  ConMed PadPro Multifunction      9/26/2021
                                                                       Electrodes, ConMed PadPro
                                                                       Multifunction Electrode
                                                                       Adapters.
P200031, FDA-2021-M-1058................  TransMedics, Inc..........  Organ Care System (OCSTM)        9/28/2021
                                                                       Liver.
P210026, FDA-2021-M-1116................  Agilent Technologies, Inc.  Ki-67 IHC MIB-1 pharmDx (Dako   10/12/2021
                                                                       Omnis).

[[Page 34887]]

 
P190012, FDA-2021-M-1119................  Spatz FGIA Inc............  Spatz3 Adjustable Balloon       10/15/2021
                                                                       System.
P160046/S010, FDA-2021-M-0532...........  Ventana Medical Systems,    VENTANA PD-L1 (SP263) Assay..   10/15/2021
                                           Inc.
P150031/S040, FDA-2021-M-1176...........  Boston Scientific           Vercise PC, Vercise Gevia and   10/20/2021
                                           Corporation.                Vercise Genus DBS Systems.
P150038/S014, FDA-2021-M-1182...........  INSIGHTEC, Inc............  Exablate Model 4000 Type 1.0      10/29/21
                                                                       and 1.1 System (``Exablate
                                                                       Neuro'').
P130026/S070, FDA-2021-M-1207...........  Abbott Medical............  TactiCath Contact Force            11/4/21
                                                                       Ablation Catheter, Sensor
                                                                       Enabled (Uni-Directional);
                                                                       TactiCath Contact Force
                                                                       Ablation Catheter, Sensor
                                                                       Enabled (Bi-Directional);
                                                                       TactiSys Quartz Equipment;
                                                                       Ampere RF Generator and Cool
                                                                       Point Irrigation Pump.
P210020, FDA-2021-M-1284................  Urotronic, Inc............  Optilume[supreg] Urethral          12/3/21
                                                                       Drug Coated Balloon.
P190022, FDA-2021-M-1271................  OPKO Health, Inc..........  4Kscore[supreg] Test.........      12/7/21
P200035, FDA-2021-M-1317................  OrganOx Limited...........  OrganOx metra[supreg] System.      12/9/21
P210014, FDA-2021-M-1321................  Svelte Medical Systems,     SLENDER Sirolimus-Eluting         12/13/21
                                           Inc.                        Coronary Stent Integrated
                                                                       Delivery System and DIRECT
                                                                       Sirolimus-Eluting Coronary
                                                                       Stent Rapid Exchange
                                                                       Delivery System.
P200041, FDA-2021-M-1316................  OrbusNeich Medical          Scoreflex NC Scoring PTCA         12/21/21
                                           (Shenzhen) Co., Ltd.        Catheter.
P200015/S011, FDA-2021-M-1325...........  Edwards Lifesciences LLC..  Edwards SAPIEN 3                  12/16/21
                                                                       Transcatheter Pulmonary
                                                                       Valve System with Alterra
                                                                       Adaptive Prestent.
P200040, FDA-2021-M-1352................  Delphinus Medical           SoftVue Automated Whole            10/6/21
                                           Technologies, Inc.          Breast Ultrasound System
                                                                       with Sequr Breast Interface
                                                                       Assembly.
P170002/S012, FDA-2022-M-0029...........  TEOXANE S.A...............  RHA[supreg] RedensityTM......     12/22/21
P970051/S205, FDA-2022-M-0071...........  Cochlear Americas.........  Nucleus 24 Cochlear Implant        1/10/22
                                                                       System.
P130022/S042, FDA-2022-M-0087...........  Nevro Corporation.........  Senza[supreg] Spinal Cord          1/18/22
                                                                       Stimulation (SCS) System.
P840001/S469, FDA-2022-M-089............  Medtronic Neuromodulation.  Restore, Itrel, Synergy,           1/21/22
                                                                       Intellis, and Vanta Spinal
                                                                       Cord Stimulation Systems,
                                                                       Pisces, Specify and Vectris
                                                                       Spinal Cord Stimulation
                                                                       Leads.
P080012/S068, FDA-2022-M-0090...........  Flowonix Medical, Inc.....  Prometra[supreg] Programmable      1/12/22
                                                                       Infusion Pump System.
P160048/S016, FDA-2022-M-0171...........  Senseonics, Incorporated..  Eversense[supreg] E3               2/10/22
                                                                       Continuous Glucose
                                                                       Monitoring System.
----------------------------------------------------------------------------------------------------------------

II. Electronic Access

    Persons with access to the internet may obtain the documents at 
https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/DeviceApprovalsandClearances/PMAApprovals/default.htm.

    Dated: June 2, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-12371 Filed 6-7-22; 8:45 am]
BILLING CODE 4164-01-P