Calendar

pharmadog

Week of Mar 16, 2026

Mar 17, 2026device pma132d agoJenaValve Technology, Inc. — Trilogy Transcatheter Heart Valve System (PMA)

Product code: NPT. Advisory committee: CV. Decision: APPR

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Mar 17, 2026device pma132d agoRoche Molecular Systems, Inc. — cobas® HPV (PMA supplement)

Supplement type: 30-Day Notice. Product code: MAQ. Advisory committee: MI. Decision: OK30

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Mar 17, 2026device pma132d agoRoche Molecular Systems, Inc. — cobas® BRAF V600 Mutation Test (PMA supplement)

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

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Mar 17, 2026device pma132d agoRoche Molecular System, Inc. — cobas® EZH2 Mutation Test (PMA supplement)

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

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Mar 17, 2026device pma132d agoRoche Molecular Systems, Inc. — cobas® KRAS Mutation Test (PMA supplement)

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

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Mar 18, 2026device pma131d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (SNS Urinary Neurostimulator) (PMA supplement)

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

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Mar 18, 2026device pma131d 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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Mar 18, 2026device pma131d agoBoston Scientific — INGEVITY+ Pace / Sense Lead Tined Fixation Models 7831 (52 cm, Straight) 7832 (59 cm, Straight) 7835 (45 cm, Atrial J (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Mar 18, 2026device pma131d agoMedtronic Neuromodulation — InterStim® Therapy System, Verify® Evaluation System (SNS Bowel Neurostimulator) (PMA supplement)

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

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Mar 18, 2026device pma131d agoMerz North America, Inc. — COAPTITE® Injectable Implant (PMA supplement)

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

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Mar 18, 2026device pma131d 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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Mar 18, 2026device pma131d agoCooperVision, Inc. — Biofinity Sphere, Biofinity XR Sphere, Biofinity Energys, Biofinity Toric, Biofinity XR Toric, Biofinity Multifocal; Bio (PMA supplement)

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

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Mar 18, 2026device pma131d agoLivaNova USA, Inc. — aura6000 system (PMA)

Product code: MNQ. Advisory committee: AN. Decision: APPR

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Mar 18, 2026device pma131d agoCarl Zeiss Meditec Production, LLC — CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621P (PMA supplement)

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

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Mar 19, 2026device pma130d agoAgilent Technologies, Inc. — PD-L1 IHC 22C3 pharmDx (PMA supplement)AGILENT TECHNOLOGIES, INC.

Supplement type: Normal 180 Day Track. Product code: PLS. Advisory committee: PA. Decision: APPR

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Mar 19, 2026device pma130d agoMedtronic Sofamor Danek USA, Inc. — INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device (PMA supplement)Medtronic USA Inc

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

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Mar 19, 2026device pma130d agoMedtronic Minimed, Inc. — Simplera Sync Sensor (PMA supplement)Medtronic USA Inc

Supplement type: 30-Day Notice. Product code: OZP. Advisory committee: CH. Decision: OK30

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Mar 19, 2026device pma130d agoMedtronic, Inc. — INFUSE® Bone Graft (PMA supplement)Medtronic plc

Supplement type: 30-Day Notice. Product code: NPZ. Advisory committee: DE. Decision: OK30

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Mar 19, 2026device pma130d agoSenseonics, Incorporated — Eversense® Continuous Glucose Monitoring System (PMA supplement)Senseonics Holdings, Inc.

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

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Mar 19, 2026device pma130d agoMedtronic Minimed, Inc. — Simplera Sync Sensor (PMA supplement)Medtronic USA Inc

Supplement type: 30-Day Notice. Product code: SFI. Advisory committee: CH. Decision: OK30

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Mar 19, 2026device pma130d agoABBOTT MEDICAL — Amplatzer Amulet Left Atrial Appendage Occluder (PMA supplement)

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

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Mar 19, 2026device pma130d agoThe Spectranetics Corp. — Stellarex 0.035 OTW Drug-Coated Angioplasty Balloon (PMA supplement)

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

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Mar 19, 2026device pma130d agoMedtronic Sofamor Danek USA, Inc. — INFUSE® Bone Graft (PMA supplement)Medtronic USA Inc

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

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Mar 19, 2026device pma130d agoProverum, Ltd. — ProVee System for BPH (PMA supplement)

Supplement type: Special (Immediate Track). Product code: MER. Advisory committee: GU. Decision: APPR

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Mar 20, 2026device pma129d agoAbbott Molecular, Inc. — Abbott RealTime IDH1 (PMA supplement)

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

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Mar 20, 2026device pma129d agoAbbott Vascular, Inc. — XACT Carotid Stent System (PMA supplement)

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

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Mar 20, 2026device pma129d agoQ-Med AB — Restylane® Contour (PMA supplement)

Supplement type: Panel Track. Product code: LMH. Advisory committee: SU. Decision: APPR

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Mar 20, 2026device pma129d agoAbbott Vascular (Idef Technologies Inc) — Supera Peripheral Stent System (PMA supplement)

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

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Mar 20, 2026device pma129d agoMicroVention, Inc. — Woven EndoBridge Aneurysm Embolization (WEB) System (PMA supplement)MICROVISION, INC.

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

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Mar 20, 2026device pma129d agoCarl Zeiss Meditec Production, LLC — CT LUCIA 602; CT LUCIA 202; CT LUCIA 611P; CT LUCIA 621P (PMA supplement)

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

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Mar 20, 2026device pma129d agoAbbott Molecular, Inc. — Abbott RealTime IDH2 (PMA supplement)

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

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Mar 20, 2026device pma129d agoMedtronic, Inc. — Sphere-9 Catheter (AFR-00001) (PMA supplement)Medtronic plc

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

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Week of Mar 23, 2026

Mar 23, 2026device pma126d agoInsightec — EXABLATE (PMA supplement)

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

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Mar 23, 2026device pma

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