Calendar

Week of Jun 16, 2025

Jun 16, 2025device pma441d agoBeckman Coulter, Inc. — Access Hybritech p2PSA (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: OYA. Advisory committee: IM. Decision: APPR

Jun 16, 2025device pma441d agoVentana Medical Systems, Inc. — VENTANA HER2 DualL ISH DNA Probe Cocktail (PMA supplement)MERIT MEDICAL SYSTEMS INC

Supplement type: 30-Day Notice. Product code: NYQ. Advisory committee: PA. Decision: OK30

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Jun 16, 2025device pma441d agoMerz North America, Inc. — RADIESSE® Injectable Implant (PMA supplement)

Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

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Jun 16, 2025device pma441d agoMerz North America, Inc. — RADIESSE® Injectable Implant, RADIESSE® Hands, RADIESSE® (+) Lidocaine, RADIESSE® (+) Jawline (PMA supplement)Sustained Therapeutics Inc

Supplement type: 30-Day Notice. Product code: LMH. Advisory committee: SU. Decision: OK30

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Jun 16, 2025device pma441d agoMerz North America, Inc. — COAPTITE® (PMA supplement)

Supplement type: 30-Day Notice. Product code: LNM. Advisory committee: GU. Decision: OK30

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Jun 17, 2025device pma440d agoMedtronic, Inc. — Astra S DR MRI IPG, X3DR01; Astra S SR MRI IPG, X3SR01; Astra XT DR MRI IPG, X1DR01; Astra XT SR MRI IPG, X1SR01; Azure (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

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Jun 17, 2025device pma440d agoABBOTT MEDICAL — Microny family of Pacemakers (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: LWO. Advisory committee: CV. Decision: APPR

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Jun 17, 2025device pma440d agoMedtronic, Inc. — CareLink SmartSync Device Manager Base, 24970A (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

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Jun 17, 2025device pma440d agoABBOTT MEDICAL — Aveir Leadless System (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: PNJ. Advisory committee: CV. Decision: APPR

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Jun 17, 2025device pma440d agoCooperVision, Inc. — MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear (PMA supplement)

Supplement type: 30-Day Notice. Product code: QIT. Advisory committee: OP. Decision: OK30

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Jun 17, 2025device pma440d agoAtriCure, Inc. — Synergy Ablation System (PMA supplement)AtriCure, Inc.

Supplement type: Normal 180 Day Track No User Fee. Product code: OCM. Advisory committee: CV. Decision: APPR

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Jun 17, 2025device pma440d agoMedtronic, Inc. — Percepta Bipolar CRT- P, WlTR0l; Percepta Quadripolar CRT-P, W4TR01; Serena Bipolar CRT-P, W1TR02; Serena Quadripolar CR (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30

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Jun 17, 2025device pma440d agoABBOTT MEDICAL — Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: NIK. Advisory committee: CV. Decision: APPR

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Jun 17, 2025device pma440d agoABBOTT MEDICAL — Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: NKE. Advisory committee: CV. Decision: APPR

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Jun 17, 2025device pma440d agoABBOTT MEDICAL — Assurity, Assurity+, Endurity, Accent family of Pacemakers (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: DXY. Advisory committee: CV. Decision: APPR

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Jun 17, 2025device pma440d agoNeuspera Medical, Inc. — Neuspera Sacral Neuromodulation System (PMA)

Product code: EZW. Advisory committee: GU. Decision: APPR

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Jun 17, 2025device pma440d agoABBOTT MEDICAL — Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: LWS. Advisory committee: CV. Decision: APPR

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Jun 17, 2025device pma440d agoABBOTT MEDICAL — Assurity MRI, Endurity MRI family of Pacemakers (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: LWP. Advisory committee: CV. Decision: APPR

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Jun 17, 2025device pma440d agoAtriCure, Inc. — EPi-Sense Guided Coagulation System (PMA supplement)AtriCure, Inc.

Supplement type: Normal 180 Day Track No User Fee. Product code: OCM. Advisory committee: CV. Decision: APPR

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Jun 17, 2025device pma440d agoCooperVision, Inc. — MiSight 1 Day (omafilcon A) (PMA supplement)

Supplement type: 30-Day Notice. Product code: QIT. Advisory committee: OP. Decision: OK30

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Jun 18, 2025device pma439d agoMedtronic, Inc. — SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LKK. Advisory committee: HO. Decision: OK30

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Jun 18, 2025device pma439d agoMedtronic, Inc. — MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma439d agoABBOTT MEDICAL — P880086 Endurity PM1162, PM2162; Endurity Core PM1140, PM2140; AV Plus Dx Lead 1368; Verity ADx XL 5357M/S, 5356, 5256, (PMA supplement)

Supplement type: 30-Day Notice. Product code: DXY. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma439d agoBiotronik, Inc. — Edora 8 DR-T 407145, Evity 8 DR-T 407146, Enitra 8 DR-T 407147, Enticos 8 DR-T 407148, Evity 6 DR-T 407149, Enitra 6 DR- (PMA supplement)

Supplement type: 30-Day Notice. Product code: DXY. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma439d agoMedtronic, Inc. — Aurora EV-ICD System (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma439d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (PMA supplement)

Supplement type: 30-Day Notice. Product code: EZW. Advisory committee: GU. Decision: OK30

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Jun 18, 2025device pma439d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (PMA supplement)

Supplement type: 30-Day Notice. Product code: QON. Advisory committee: GU. Decision: OK30

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Jun 18, 2025device pma439d agoABBOTT MEDICAL — Endurity MRI PM1172, PM2172; Assurity MRI PM1272, PM2272; Zenex MRI PM1282, PM2282; Zenus MRI PM1182, PM2182; Accent MRI (PMA supplement)

Supplement type: 30-Day Notice. Product code: LWP. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma439d agoABBOTT MEDICAL — Aveir LSP112V, LSP201A, LSP202V (PMA supplement)

Supplement type: 30-Day Notice. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma439d agoSeikagaku Corp. — Gel-One (PMA supplement)Seikagaku Corp

Supplement type: 30-Day Notice. Product code: MOZ. Advisory committee: OR. Decision: OK30

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Jun 18, 2025device pma439d agoEBR Systems, Inc. — WiSE® (Wireless Stimulation of the Endocardium Technology) CRT System (PMA supplement)EBR Systems, Inc.

Supplement type: Normal 180 Day Track No User Fee. Product code: SEG. Advisory committee: CV. Decision: APPR

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Jun 18, 2025device pma439d agoAlcon Research, Ltd. — AcrySof IQ ReSTOR Posterior Chamber Intraocular Lenses (PMA supplement)Rubicon Research Ltd

Supplement type: Normal 180 Day Track No User Fee. Product code: MFK. Advisory committee: OP. Decision: APPR

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Jun 18, 2025device pma439d agoAlcon Laboratories, LLC — Clareon Aspheric Hydrophobic Acrylic Intraocular Lenses (PMA supplement)Alcon Laboratories Inc

Supplement type: Normal 180 Day Track No User Fee. Product code: HQL. Advisory committee: OP. Decision: APPR

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Jun 18, 2025device pma439d agoABBOTT MEDICAL — Allure PM3120; Allure Quadra RF PM3242; Allure Quadra PM3140; Allure RF PM3222; Anthem PM3210; Quadra Allure PM3542; (PMA supplement)

Supplement type: 30-Day Notice. Product code: NKE. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma439d agoABBOTT MEDICAL — IsoFlex Optim Lead 1944, 1948 (PMA supplement)

Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma439d agoMedtronic Neuromodulation — Restore, Itrel®, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify®, and Vect (PMA supplement)

Supplement type: 30-Day Notice. Product code: LGW. Advisory committee: NE. Decision: OK30

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Jun 18, 2025device pma439d agoNeomend, Inc. — TRIDYNE Vascular Sealant (PMA supplement)

Supplement type: 30-Day Notice. Product code: NBE. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma439d agoMentor Corp. — MENTOR MemoryGel Enhance Breast Implants (PMA supplement)

Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30

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Jun 18, 2025device pma439d agoEdwards Lifesciences, LLC — Edwards EVOQUE Tricuspid Valve Replacement System (PMA supplement)Edwards Lifesciences Corp

Supplement type: 30-Day Notice. Product code: NPW. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma439d agoInfusyn Therapeutics, LLC — PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM (PMA supplement)LIB Therapeutics LLC

Supplement type: Normal 180 Day Track No User Fee. Product code: LKK. Advisory committee: HO. Decision: APPR

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Jun 18, 2025device pma439d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DDPB3D1, DDPB3D4; Cobalt MRI ICD DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DVPA2D1, DVPA2D4; Cobalt XT (PMA supplement)

Supplement type: 30-Day Notice. Product code: LWS. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma439d agoABBOTT MEDICAL — Durata 7120, 7121, 7122, 7130, 7131, 7170, 7171, 7120, 7120Q, 7121Q, 7122, 7122Q, 7170Q, 7171Q, 7172Q; Optisure LDA210, (PMA supplement)

Supplement type: 30-Day Notice. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma439d agoCerapedics, Inc. — PearlMatrix Bone Graft (PMA)

Product code: NOX. Advisory committee: OR. Decision: APPR

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Jun 18, 2025device pma439d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4; Brava CRT-D DTBC1D1; Bra (PMA supplement)

Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma439d agoMedtronic, Inc. — Micra AV TPS MC1AVR1, Micra AV2 TPS MC2AVR1, Micra TPS MC1VR01, Micra VR2 TPS MC2VR01 (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: PNJ. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma439d agoABBOTT MEDICAL — OptiSense 1999; Tendril SDX Lead 1688T/TC DTB; Tendril ST Lead 1888TC, 1882TC; Tendril STS Lead 2088TC; Tendril STS Lead (PMA supplement)

Supplement type: 30-Day Notice. Product code: NVN. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma439d agoABBOTT MEDICAL — Avant HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Entrant HF CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T; Gallant HF C (PMA supplement)

Supplement type: 30-Day Notice. Product code: NIK. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma439d agoInspire Medical Systems — Inspire® Upper Airway Stimulation (UAS) (PMA supplement)Inspire Medical Systems, Inc.

Supplement type: 30-Day Notice. Product code: MNQ. Advisory committee: AN. Decision: OK30

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Jun 18, 2025device pma439d agoBiotronik, Inc. — Edora 8 HF-T QP 407137, Edora 8 HF-T 407138, Evity 8 HF-T QP 407139, Evity 8 HF-T 407140, Enitra 8 HF-T QP 407141, Enitr (PMA supplement)

Supplement type: 30-Day Notice. Product code: NKE. Advisory committee: CV. Decision: OK30

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Jun 18, 2025device pma439d agoMedtronic, Inc. — SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: NVZ. Advisory committee: CV. Decision: OK30

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Week of Jun 16, 2025