Calendar

Week of Jul 14, 2025

Jul 16, 2025device pma369d 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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Jul 16, 2025device pma369d agoMedtronic Cardiac Rhythm Disease Management — CapSure SP Z Lead 5033; Vitatron Impulse II Lead IHP09, IHP09B, IHP09JB (PMA supplement)

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

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Jul 16, 2025device pma369d agoZoll Manufacturing Corporation — LifeVest® Wearable Defibrillator (PMA supplement)

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

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Jul 16, 2025device pma369d agoBiotronik, Inc. — Astron (PMA supplement)

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

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Jul 16, 2025device pma369d agoMedtronic, Inc. — CapSure Epicardial Pacing Lead 4965; CapSure Epicardial Pacing Lead 4968 (PMA supplement)Medtronic plc

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

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Jul 16, 2025device pma369d agoBoston Scientific Corp — WATCHMAN FLX Left Atrial Appendage (LAA) Closure Technology, WATCHMAN FLX Left Atrial Appendage Closure Device with Deli (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Panel Track. Product code: NGV. Advisory committee: CV. Decision: APPR

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Jul 16, 2025device pma369d agoSiemens Healthcare Diagnostics, Inc. — ADVIA Centaur® AFP Immunoassay; Atellica IM Alpha Fetoprotein (AFP) (PMA supplement)

Supplement type: 30-Day Notice. Product code: LOK. Advisory committee: IM. Decision: OK30

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Jul 16, 2025device pma369d agoSiemens Healthcare Diagnostics — ADVIA Centaur® Complexed PSA (cPSA) Immunoassay; Atellica IM Complexed Prostate-Specific Antigen (cPSA) (PMA supplement)

Supplement type: 30-Day Notice. Product code: NAF. Advisory committee: IM. Decision: OK30

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Jul 16, 2025device pma369d agoW. L. Gore & Associates, Inc. — GORE® TAG® Conformable Thoracic Endoprosthesis (PMA supplement)

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

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Jul 16, 2025device pma369d 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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Jul 16, 2025device pma369d agoValencia Technologies Corporation — eCoin Peripheral Neurostimulator (PMA supplement)

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

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Jul 16, 2025device pma369d agoMedtronic, Inc. — CapSureFix Novus Lead 5076; Vitatron Crystalline ActFix Lead ICF09B (PMA supplement)Medtronic plc

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

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Jul 16, 2025device pma369d agoSiemens Healthcare Diagnostics — ADVIA Centaur® PSA Immunoassay; Atellica IM Prostate-Specific Antigen (PSA) (PMA supplement)

Supplement type: 30-Day Notice. Product code: MTG. Advisory committee: IM. Decision: OK30

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Jul 16, 2025device pma369d agoMedtronic, Inc. — print Quattro Lead 6935M; Sprint Quattro Lead 6947M; Sprint Quattro Lead 6947; Sprint Quattro Lead 6935 (PMA supplement)Medtronic plc

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

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Jul 16, 2025device pma369d agoMedtronic, Inc. — CapSure VDD-2 Lead 5038, 5038L, 5038S; Vitatron Brilliant S+ VDD Lead IMW14Q, IMW15Q, IMW16Q; Vitatron Brilliant S+VDD L (PMA supplement)Medtronic plc

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

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Jul 16, 2025device pma369d agoMedtronic, Inc. — Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (PMA supplement)Medtronic plc

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

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Jul 16, 2025device pma369d agoZoll Manufacturing Corporation — WEARABLE CARDIOVERTER DEFIBRILLATOR (WCD) 2000 LIFEVEST (PMA supplement)

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

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Jul 17, 2025device pma368d agoABBOTT MEDICAL — HeartMate II Left Ventricular Assist System (PMA supplement)

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

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Jul 17, 2025device pma368d 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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Jul 17, 2025device pma368d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (PMA supplement)

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

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Jul 17, 2025device pma368d 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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Jul 17, 2025device pma368d agoMedtronic Neuromodulation — Master Restore, Itrel, Synergy, Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces-Quad, Spe (PMA supplement)

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

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Jul 17, 2025device pma368d agoMedtronic Neuromodulation — Master Restore, Itrel®, Synergy Intellis, Vanta and Inceptiv Spinal Cord Stimulation Systems and Pisces, Specify®, a (PMA supplement)

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

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Jul 17, 2025device pma368d agoMedtronic, Inc. — Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (PMA supplement)Medtronic plc

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

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Jul 17, 2025device pma368d 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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Jul 17, 2025device pma368d 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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Jul 17, 2025device pma368d agoMedtronic Vascular, Inc. — Protégé RX Carotid Stent System (PMA supplement)

Supplement type: Special (Immediate Track). Product code: NIM. Advisory committee: CV. Decision: APPR

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Jul 17, 2025device pma368d agoMedtronic, Inc. — Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (PMA supplement)Medtronic plc

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

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Jul 17, 2025device pma368d 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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Jul 17, 2025device pma368d 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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Jul 18, 2025device pma367d agoExact Sciences Corporation — Cologuard® (PMA supplement)

Supplement type: Real-Time Process. Product code: PHP. Advisory committee: PA. Decision: APPR

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Jul 18, 2025device pma367d agoExact Sciences Corporation — Cologuard Plus (PMA supplement)

Supplement type: Real-Time Process. Product code: PHP. Advisory committee: PA. Decision: APPR

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Jul 18, 2025device pma367d agoBerlin Heart, Inc. — EXCOR Pediatric Ventricular Assist Device (PMA supplement)

Supplement type: Real-Time Process. Product code: DSQ. Advisory committee: CV. Decision: APPR

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Jul 18, 2025device pma367d agoFerrosan Meidcal Devices A/S — SURGIFLO® Hemostatic Matrix; SURGIFLO® Hemostatic Matrix Kit with Thrombin (PMA supplement)PFIZER INC

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

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Jul 18, 2025device pma367d agoPhraxis, Inc. — EndoForce Connector for Endovascular Venous Anastomosis (PMA supplement)

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

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Jul 18, 2025device pma367d agoOrganox Limited — OrganOx metra® System (PMA supplement)

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

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Jul 18, 2025device pma367d agoAlcon Laboratories, LLC — Clareon Aspheric Hydrophobic Acrylic Intraocular Lens (IOL), Clareon ToricAspheric Hydrophobic Acrylic Intraocular Lens, (PMA supplement)Alcon Laboratories Inc

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

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Jul 18, 2025device pma367d agoDepuy, Inc. — LCS(R) TOTAL KNEE SYSTEM (PMA supplement)

Supplement type: 135 Review Track For 30-Day Notice. Product code: NJL. Advisory committee: OR. Decision: APPR

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Week of Jul 21, 2025

Jul 21, 2025device pma364d agoAdvanced Breath Diagnostics — 13C-Gastric Emptying Breath Test (GEBT), 13C-Spirulina Gastric Emptying Breath Test (GEBT), 13C-GEBT (PMA supplement)

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

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Jul 21, 2025device pma

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