Calendar

pharmadog

Week of Jun 16, 2025

Jun 18, 2025device pma395d 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 pma395d 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 pma395d 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 pma395d 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 pma395d 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 pma395d 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 pma395d 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 pma395d 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 pma395d 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 pma395d 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 pma395d 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 pma395d 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 pma395d 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 pma395d 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 pma395d agoCerapedics, Inc. — PearlMatrix Bone Graft (PMA)

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

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Jun 18, 2025device pma395d 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 pma395d 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 pma395d 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 pma395d 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 pma395d 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 pma395d 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 pma395d 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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Jun 18, 2025device pma395d agoABBOTT MEDICAL — Gallant DR CDDRA500Q; Gallant VR CDVRA500Q; Neutrino NxT DR CDDRA800Q; Neutrino NxT DR CDDRA600Q; Neutrino NxT VR CDVRA8 (PMA supplement)

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

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Jun 18, 2025device pma395d agoMedtronic, Inc. — Consulta CRT-P C4TR01; Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRTP W4TR01; Serena Bipolar CRT-P W1TR02; Ser (PMA supplement)Medtronic plc

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

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Jun 18, 2025device pma395d agoIntersect Ent. — PROPEL, PROPEL MINI and PROPEL CONTOUR (PMA supplement)

Supplement type: 30-Day Notice. Product code: OWO. Advisory committee: EN. Decision: OK30

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Jun 18, 2025device pma395d agoBausch & Lomb, Inc. — enVista® Hydrophobic Acrylic Intraocular Lens (IOL) (PMA supplement)Bausch & Lomb Corp

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

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Jun 18, 2025device pma395d agoCaris Life Sciences — MI Cancer Seek (PMA supplement)Caris Life Sciences, Inc.

Supplement type: 30-Day Notice. Product code: PQP. Advisory committee: MG. Decision: OK30

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Jun 18, 2025device pma395d agoBiotronik, Inc. — Acticor 7 VR-T 429526, Rivacor 7 VR-T 429536, Rivacor 5 VR-T 429565, Rivacor 3 VR-T 429574, Acticor 7 VR-T DX 429525, Ri (PMA supplement)

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

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Jun 18, 2025device pma395d agoAlcon Laboratories, Inc. — AcrySof Posterior Chamber Intraocular Lenses and Delivery Systems (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 pma395d 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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Jun 18, 2025device pma395d agoNeomend, Inc. — PROGEL Pleural Air Leak Sealant (PMA supplement)

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

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Jun 20, 2025device pma393d agoABBOTT MEDICAL — TactiFlex Ablation Catheter, Sensor Enabled (PMA supplement)

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

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Jun 20, 2025device pma393d agoMedtronic, Inc. — CapSureFix Novus Lead (PMA supplement)Medtronic plc

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

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Jun 20, 2025device pma393d agoVentana Medical Systems, Inc. — PATHWAY® Anti-c-KIT (9.7) Primary Antibody (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

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Jun 20, 2025device pma393d agoVentana Medical Systems, Inc. — VENTANA CLDN18 (43-14A) RxDx Assay (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

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Jun 20, 2025device pma393d agoMainstay Medical Limited — ReActiv8 Implantable Neurostimulation System (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: QLK. Advisory committee: NE. Decision: APPR

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Jun 20, 2025device pma393d agoZOLL Medical Corporation — AED Plus and Fully Automatic AED Plus (PMA supplement)

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

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Jun 20, 2025device pma393d agoZoll Circulation, Inc. — TherOx Downstream Cartridge (PMA supplement)

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

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Jun 20, 2025device pma393d agoCeramtec GmbH — Transcend® Hip Articulation System (PMA supplement)

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

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Jun 20, 2025device pma393d agoZOLL Medical Corporation — X Series®, R Series®, AED Pro®, AED 3 BLS Professional Defibrillators, Pro-Padz Radiotransparent Electrode, SurePower (PMA supplement)

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

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Jun 20, 2025device pma393d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

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

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Jun 20, 2025device pma393d agoSt Jude Medical — TactiCath Contact Force Ablation Catheter, Sensor Enabled (PMA supplement)

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

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Jun 20, 2025device pma393d agoVentana Medical Systems, Inc. — VENTANA FOLR1 (FOLR-2.1) RxDx Assay (PMA supplement)MERIT MEDICAL SYSTEMS INC

Supplement type: 30-Day Notice. Product code: QUL. Advisory committee: MG. Decision: OK30

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Jun 20, 2025device pma393d agoAbiomed, Inc. — IMPELLA CP with Smart Assist (PMA supplement)Abion Inc

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

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Jun 20, 2025device pma393d agoVentana Medical Systems, Inc. — PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

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Jun 20, 2025device pma393d agoPhysio-Control, Inc. — LIFEPAK® CR2 Defibrillator (PMA supplement)

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

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Jun 20, 2025device pma393d agoVentana Medical Systems, Inc. (Roche Tissue Diagnostics) — VENTANA MET (SP44) RxDx Assay (PMA supplement)

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

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Jun 20, 2025device pma393d agoPhilips Medical Systems, Inc. — HeartStart OnSite Defibrillator (Model M5066A) and HeartStart Home Defibrillator (Model M5068A) (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

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Jun 20, 2025device pma393d agoVentana Medical Systems, Inc. — VENTANA ALK (D5F3) CDX ASSAY (PMA supplement)MERIT MEDICAL SYSTEMS INC

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

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Jun 20, 2025device pma393d agoPhysio-Control, Inc. — LIFEPAK 15 monitor/defibrillator; LIFEPAK 35 monitor/defibrillator; LIFEPAK 20e defibrillator/monitor; LIFEPAK 1000 defi (PMA supplement)

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

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Week of Jun 16, 2025