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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].
 AGENCY: Food and Drug Administration, HHS.
 ACTION: Notice.
 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-
                    ( print 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, 
                        *Dharmesh.Patel@fda.hhs.gov.*


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 § 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
PMA No., docket No.
Applicant
Trade name
Approval dateP200003, FDA-2021-M-0070
Seno Medical Instruments, Inc
Imagio® Breast Imaging System
1/11/21P200028, FDA-2021-M-0135
Medtronic, Inc
DiamondTemp
                            TM
                             Ablation System consisting of DiamondTemp
                            TM
                             AblaDiamondTemp Ablation Catheter (Models CEDT100S, CEDT200L, CEDTB300S, CEDTB400L); DiamondTemp
                            TM
                             RF Generator (Model CEDTG200); DiamondTemp
                            TM
                             Irrigation Pump (Model CEDTP100); DiamondTemp
                            TM
                             Irrigation Tubing Set (Model CEDTTS100); DiamondTemp
                            TM
                             Catheter-to-RF Generator Cable (Model CEDTC100); DiamondTemp
                            TM
                             GenConnect Cable (Model CEDTGC100); DiamondTemp
                            TM
                             EGM Cable (Model CEDTEGM100)
1/28/2021P140029/S027, FDA-2021-M-0153
Q-Med AB
Restylane® Defyne
1/29/2021P190005, FDA-2021-M-0178
Roche Diagnostics
Elecsys Anti-HBe, PreciControl Anti-HBe
2/3/2021P200039, FDA-2021-M-0202
Shockwave Medical, Inc
Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave C2
                             Coronary Intravascular Lithotripsy (IVL) Catheter
2/12/2021P190013, FDA-2021-M-0288
AED Battery Exchange, LLC
AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE)
2/13/2021( print page 34886)H200001, FDA-2021-M-0203
Additive Orthopaedics, LLC
Patient Specific Talus Spacer
2/17/2021P190034, FDA-2021-M-0228
Roche Diagnostics
Elecsys Anti-HBs II, PreciControl Anti-HBs, Anti-HBs CalCheck
2/23/2021P200029, FDA-2021-M-0303
Boston Scientific Corporation
TheraSphere
                            TM
3/17/2021P200025, FDA-2021-M-0325
Bausch Health
ClearVisc Ophthalmic Viscosurgical Device (OVD)
3/23/2021P200046, FDA-2021-M-0354
Medtronic, Inc
Medtronic Harmony Transcatheter Pulmonary Valve (TPV) System
3/26/2021P200022/S003, FDA-2021-M-0355
Simplify Medical, Inc
Simplify® Cervical Artificial Disc
4/1/2021P200019, FDA-2021-M-0416
Ventana Medical Systems, Inc
VENTANA MMR RxDx Panel
4/22/2021P980040/S124, FDA-2021-M-0421
Johnson & Johnson Surgical Vision, Inc
TECNIS Synergy
                            TM
                             IOL, Model ZFR00V, TECNIS Synergy
                            TM
                             Toric II IOL, Models ZFW150, ZFW225, ZFW300, ZFW375, TECNIS Synergy
                            TM
                             IOL with TECNIS Simplicity
                            TM
                             Delivery System, Model DFR00V, TECNIS Synergy
                            TM
                             Toric II IOL with TECNIS Simplicity
                            TM
                             Delivery System, Model DFW150, DFW225, DFW300, DFW375
4/28/2021P200002, FDA-2021-M-0418
AtriCure, Inc
EPi-Sense® Guided Coagulation System
4/28/21P140031/S125, FDA-2021-M-0473
Edwards Lifesciences, LLC
Edwards SAPIEN 3 and SAPIEN 3 Ultra Transcatheter Heart Valve System
5/13/21P200010/S001, FDA-2021-M-0520
Guardant Health, Inc
Guardant360 CDx
5/21/2021P110027/S012, FDA-2021-M-0531
QIAGEN GmbH
therascreen® KRAS RGQ PCR Kit
5/28/2021P110033/S053, FDA-2021-M-0527
Allergan
JUVÉDERM® VOLBELLA® XC
5/28/2021P200010/S002, FDA-2021-M-0494
Guardant Health, Inc
Guardant360 CDx
5/28/2021P100010/S110, FDA-2021-M-0690
Medtronic, Inc
Arctic Front AdvanceTM Cardiac Cryoablation Catheters, Arctic Front Advance ProTM Cardiac Cryoablation Catheters, FreezorTM MAX Cardiac Cryoablation Catheter, CryoConsole Manual Retraction Kit
6/18/2021P200021, FDA-2021-M-0615
Oticon Medical
Neuro Cochlear Implant System
6/23/2021P110019/S115, FDA-2021-M-0656
Abbott Vascular
XIENCE Alpine Everolimus 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)
6/25/2021P140029/S032, FDA-2021-M-0676
Q-Med AB, a Galderma affiliate
Restylane® Contour
6/28/2021P200017, FDA-2021-M-0766
Siemens Healthcare Diagnostics Inc
ADVIA Centaur® Anti-HBe2 (aHBe2) assay
7/14/2021P190032/S001, FDA-2021-M-0707
Foundation Medical, Inc
FoundationOne® Liquid CDx (F1 Liquid)
7/15/21P130022/S039, FDA-2021-M-0769
Nervo Corporation
Senza® Spinal Cord Stimulation (SCS) System
7/16/2021P200037, FDA-2021-M-0820
Kestra Medical Technologies, Inc
ASSURE® Wearable Cardioverter Defibrillator (WCD) System (ASSURE System)
7/27/2021P200011, FDA-2021-M-0853
Pillar Biosciences, Inc
ONCO/Reveal
                            TM
                             Dx Lung & Colon Cancer Assay
7/30/2021P200045, FDA-2021-M-0805
Bolton Medical, Inc
RelayPro Thoracic Stent-Graft System
8/5/2021P200049, FDA-2021-M-0911
Abbott Medical
Amplatzer
                            TM
                             Amulet
                            TM
                             Left Atrial Appendage Occluder
8/14/2021P210001, FDA-2021-M-0915
Ventana Medical Systems, Inc
VENTANA MMR RxDx Panel
8/17/2021P160045/S028, FDA-2021-M-0962
Life Technologies Corporation
Oncomine® Dx Target Test
8/25/2021P210007, FDA-2021-M-0991
MicroTransponder Inc
MicroTransponder® Vivistim® Paired VNS
                            TM
                             System (Vivistim® System)
8/27/2021P050052/S129, FDA-2021-M-0975
Merz North America, Inc
RADIESSE® (+) Lidocaine injectable implant
9/1/2021P180051, FDA-2021-M-0989
TransMedics, Inc
Organ Care System (OCS
                            TM
                            ) Heart System
9/3/2021P160045/S029, FDA-2021-M-1023
Life Technologies Corporation
Oncomine
                            TM
                             Dx Target Test
9/15/2021P190023, FDA-2021-M-1010
Abbott Medical
Portico
                            TM
                             Transcatheter Aortic Valve Implantation System: Portico
                            TM
                             Transcatheter Aortic Heart Valve, FlexNav
                            TM
                             Delivery System, FlexNav
                            TM
                             Loading System
9/17/2021P200004, FDA-2021-M-1046
ConMed Corporation
ConMed PadPro Multifunction Electrodes, ConMed PadPro Multifunction Electrode Adapters
9/26/2021P200031, FDA-2021-M-1058
TransMedics, Inc
Organ Care System (OCS
                            TM
                            ) Liver
9/28/2021P210026, FDA-2021-M-1116
Agilent Technologies, Inc
Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
10/12/2021( print page 34887)P190012, FDA-2021-M-1119
Spatz FGIA Inc
Spatz3 Adjustable Balloon System
10/15/2021P160046/S010, FDA-2021-M-0532
Ventana Medical Systems, Inc
VENTANA PD-L1 (SP263) Assay
10/15/2021P150031/S040, FDA-2021-M-1176
Boston Scientific Corporation
Vercise PC, Vercise Gevia and Vercise Genus DBS Systems
10/20/2021P150038/S014, FDA-2021-M-1182
INSIGHTEC, Inc
Exablate Model 4000 Type 1.0 and 1.1 System (“Exablate Neuro”)
10/29/21P130026/S070, FDA-2021-M-1207
Abbott Medical
TactiCath Contact Force 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
11/4/21P210020, FDA-2021-M-1284
Urotronic, Inc
Optilume® Urethral Drug Coated Balloon
12/3/21P190022, FDA-2021-M-1271
OPKO Health, Inc
4Kscore® Test
12/7/21P200035, FDA-2021-M-1317
OrganOx Limited
OrganOx metra® System
12/9/21P210014, FDA-2021-M-1321
Svelte Medical Systems, Inc
SLENDER Sirolimus-Eluting Coronary Stent Integrated Delivery System and DIRECT Sirolimus-Eluting Coronary Stent Rapid Exchange Delivery System
12/13/21P200041, FDA-2021-M-1316
OrbusNeich Medical (Shenzhen) Co., Ltd
Scoreflex NC Scoring PTCA Catheter
12/21/21P200015/S011, FDA-2021-M-1325
Edwards Lifesciences LLC
Edwards SAPIEN 3 Transcatheter Pulmonary Valve System with Alterra Adaptive Prestent
12/16/21P200040, FDA-2021-M-1352
Delphinus Medical Technologies, Inc
SoftVue Automated Whole Breast Ultrasound System with Sequr Breast Interface Assembly
10/6/21P170002/S012, FDA-2022-M-0029
TEOXANE S.A
RHA® Redensity
                            TM
12/22/21P970051/S205, FDA-2022-M-0071
Cochlear Americas
Nucleus 24 Cochlear Implant System
1/10/22P130022/S042, FDA-2022-M-0087
Nevro Corporation
Senza® Spinal Cord Stimulation (SCS) System
1/18/22P840001/S469, FDA-2022-M-089
Medtronic Neuromodulation
Restore, Itrel, Synergy, Intellis, and Vanta Spinal Cord Stimulation Systems, Pisces, Specify and Vectris Spinal Cord Stimulation Leads
1/21/22P080012/S068, FDA-2022-M-0090
Flowonix Medical, Inc
Prometra® Programmable Infusion Pump System
1/12/22P160048/S016, FDA-2022-M-0171
Senseonics, Incorporated
Eversense® E3 Continuous Glucose Monitoring System
2/10/22
 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