Calendar

Week of Sep 29, 2025

Sep 29, 2025device pma334d agoLungpacer Medical USA, Inc. — AeroPace® System (PMA supplement)

Supplement type: Real-Time Process. Product code: SDL. Advisory committee: AN. Decision: APPR

Sep 29, 2025device pma334d agoPhysio-Control, Inc. — LIFEPACK® CR2 Automated External Defibrillator (AED) (PMA supplement)

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

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Sep 29, 2025device pma334d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

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

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Sep 29, 2025device pma334d agoZOLL Medical Corporation — ZOLL Zenix® Monitor/Defibrillator (PMA supplement)

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

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Sep 29, 2025device pma334d agoHeartsine Technologies, Ltd. — HeartSine Technologies LLC's samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) (PMA supplement)TAT TECHNOLOGIES LTD

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

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Sep 29, 2025device pma334d agoAbbott — CentriMag Circulatory Support System (PMA supplement)

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

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Sep 29, 2025device pma334d agoBard Peripheral Vascular, Inc. — LifeStream Balloon Expandable Vascular Covered Stent (PMA supplement)

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

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Sep 29, 2025device pma334d agoInspire Medical Systems — Model 2740 Inspire Programmer; Model 2740S/C SleepSync Programming System (PMA supplement)Inspire Medical Systems, Inc.

Supplement type: Real-Time Process. Product code: MNQ. Advisory committee: AN. Decision: APPR

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Sep 30, 2025device pma333d agoAsahi Kasei Medical Co., Ltd. — Plasmaflo OP-05W(A) (PMA supplement)

Supplement type: Real-Time Process. Product code: MDP. Advisory committee: GU. Decision: APPR

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Sep 30, 2025device pma333d agoBausch & Lomb, Inc. — Akreos Posterior Chamber Intraocular Lens (PMA supplement)Bausch & Lomb Corp

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

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Sep 30, 2025device pma333d agoABBOTT MEDICAL — AVEIR Leadless Pacemaker Real-time Clock (RTC) electrical test (PMA supplement)

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

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Sep 30, 2025device pma333d agoABBOTT MEDICAL — TriClip G4 Delivery System; TriClip G5 Delivery System (PMA supplement)

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

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Sep 30, 2025device pma333d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

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

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Sep 30, 2025device pma333d agoABBOTT MEDICAL — MitraClip G4 Clip Delivery System; MitraClip G5 Delivery System (PMA supplement)

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

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Oct 1, 2025device pma332d agoAbiomed, Inc. — Impella 5.5 with SmartAssist (PMA supplement)Abion Inc

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

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Oct 1, 2025device pma332d agoBiotronik, Inc. — Ilivia 7 VR-T DX; Intica 7 VR-T DX; Intica 5 VR-T DX; Ilivia 7 VR-T; Ilivia 7 DF4 VR-T; Intica 7 VR-T; Intica 7 DF4 VR-T (PMA supplement)

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

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Oct 1, 2025device pma332d agoKARL STORZ Endoscopy-America, Inc. — Photodynamic Diagnostic D-Light C System (PMA supplement)

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

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Oct 1, 2025device pma332d agoBiotronik, Inc. — Ilivia Neo 7 DR-T; Intica Neo 7 DR-T; Intica Neo 5 DR-T (PMA supplement)

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

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Oct 1, 2025device pma332d agoBiotronik, Inc. — Ilivia Neo 7 VR-T DX; Ilivia Neo 7 VR-T; Intica Neo 7 VR-T DX; Intica Neo 7 VR-T; Intica Neo 5 VR-T DX; Intica Neo 5 VR- (PMA supplement)

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

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Oct 1, 2025device pma332d agoBiotronik, Inc. — Edora 8 DR-T; Evity 8 DR-T; Enitra 8 DR-T; Enticos 8 DR-T; Evity 6 DR-T; Enitra 6 DR-T; Edora 8 DR; Enitra 6 DR; Edora 8 (PMA supplement)

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

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Oct 1, 2025device pma332d agoRayner Intraocular Lenses , Ltd. — Rayner C-flex 570C, C-flex Aspheric 970C, 600C Aspheric, RayOne Aspheric RAO600C, RayOne Spheric RAO100C and RayOne EMV (PMA supplement)

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

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Oct 2, 2025device pma331d agoEdwards Lifesciences, LLC — PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS (PMA supplement)Edwards Lifesciences Corp

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

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Oct 2, 2025device pma331d 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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Oct 2, 2025device pma331d agoMedtronic Minimed, Inc. — MiniMed 670G System (PMA supplement)Medtronic USA Inc

Supplement type: Special (Immediate Track). Product code: OZP. Advisory committee: CH. Decision: APPR

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Oct 2, 2025device pma331d agoMedtronic, Inc. — Percepta Bipolar CRTP; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P; (PMA supplement)Medtronic plc

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

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Oct 2, 2025device pma331d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Attesta DR (PMA supplement)Medtronic plc

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

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Oct 2, 2025device pma331d agoMedinol, Ltd. — EluNIR Ridaforolimus Eluting Coronary Stent System (PMA supplement)IGC Pharma, Inc.

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

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Oct 2, 2025device pma331d agoEdwards Lifesciences, LLC — Edwards Commander Delivery System: 9600LDS23, 9600LDS26, 9600LDS29 9750CM23, 9750CM26, 9750CM29 (PMA supplement)Edwards Lifesciences Corp

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

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Oct 2, 2025device pma331d agoEdwards Lifesciences, LLC — Edwards Commander Delivery System: 9600LDS23, 9600LDS26, 9600LDS29 9750CM23, 9750CM26, 9750CM29 (PMA supplement)Edwards Lifesciences Corp

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

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Oct 2, 2025device pma331d agoBoston Scientific Corp — AMS 700 Inflatable Penile Prosthesis with and without InhibiZone (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Oct 2, 2025device pma331d agoMedtronic, Inc. — Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra (PMA supplement)Medtronic plc

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

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Oct 2, 2025device pma331d agoMedtronic Vascular, Inc. — EverFlex Self-expanding Peripheral Stent System (PMA supplement)

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

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Oct 2, 2025device pma331d agoValencia Technologies Corporation — eCoin Tibial Nerve Stimulator System (PMA supplement)

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

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Oct 3, 2025device pma330d agoNyxoah S.A. — Genio® System 2.1 (PMA supplement)Nyxoah SA

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

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Oct 3, 2025device pma330d agoMedtronic, Inc. — Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT SR MRI IPG; Astra (PMA supplement)Medtronic plc

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

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Oct 3, 2025device pma330d agoMedtronic, Inc. — Aurora EV ICD (DVEA3E4) (PMA supplement)Medtronic plc

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

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Oct 3, 2025device pma330d agoEBR Systems, Inc. — WiSE (Wireless Stimulation of the Endocardium Technology) CRT System (PMA supplement)EBR Systems, Inc.

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

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Oct 3, 2025device pma330d agoQIAGEN GmbH — QIAGEN therascreen® FGFR RGQ RT-PCR Kit (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: OWD. Advisory committee: MG. Decision: APPR

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Oct 3, 2025device pma330d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I (PMA supplement)

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

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Oct 3, 2025device pma330d agoAlcon Research, Ltd. — PROVISC Ophthalmic Viscosurgical Device (PMA supplement)Rubicon Research Ltd

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

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Oct 3, 2025device pma330d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ; Cobalt XT MRI CRTD DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ; Crome MRI CR (PMA supplement)

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

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Oct 3, 2025device pma330d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua (PMA supplement)

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

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Oct 3, 2025device pma330d agoUromedica, Inc. — ProACT Adjustable Continence Therapy for Men (PMA supplement)

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

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Oct 3, 2025device pma330d agoAlcon Laboratories — VISCOAT Ophthalmic Viscosurgical Device; DUOVISC Ophthalmic Viscoelastic System; DISCOVISC Ophthalmic Viscosurgical D (PMA supplement)Alcon Laboratories Inc

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

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Oct 3, 2025device pma330d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D (PMA supplement)

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

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Oct 3, 2025device pma330d agoMedtronic, Inc. — Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola (PMA supplement)Medtronic plc

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

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Oct 4, 2025device pma329d agoABBOTT MEDICAL — Tendyne Transcatheter Mitral Valve System (PMA supplement)

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

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Week of Oct 6, 2025

Oct 6, 2025device pma327d agoOphtec BV — Capsular Tension Ring (275,276); RingJect (375,376) (PMA supplement)

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

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Oct 6, 2025device pma

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Week of Sep 29, 2025

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