Calendar

Week of Feb 9, 2026

Feb 11, 2026device pma165d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (PMA supplement)

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

Feb 11, 2026device pma165d agoAgilent Technologies, Inc. — PD-L1 IHC 22C3 pharmDx (PMA supplement)AGILENT TECHNOLOGIES, INC.

Supplement type: Panel Track. Product code: PLS. Advisory committee: PA. Decision: APPR

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Feb 12, 2026device pma164d agoMedtronic, Inc. — Melody Transcatheter Pulmonary Valve (PMA supplement)Medtronic plc

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

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Feb 12, 2026device pma164d agoMedtronic, Inc. — Avalus Bioprostheses (PMA supplement)Medtronic plc

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

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Feb 12, 2026device pma164d agoEdwards Lifesciences, LLC — Edwards Commander Delivery System (9600LDS20, 9600LDS23 9600LDS26, 9600LDS29) (PMA supplement)Edwards Lifesciences Corp

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

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Feb 12, 2026device pma164d agoAxora Medical, Inc. — Minerva Endometrial Ablation System (PMA supplement)AVITA Medical, Inc.

Supplement type: 30-Day Notice. Product code: MNB. Advisory committee: OB. Decision: OK30

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Feb 12, 2026device pma164d agoAbbott Laboratories — ARCHITECT Total PSA; Alinity i Total PSA (LN 6C06/07P92) (PMA supplement)ABBOTT LABORATORIES

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

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Feb 12, 2026device pma164d agoIntegrum AB — OPRA Implant System (PMA supplement)

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

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Feb 12, 2026device pma164d agoBoston Scientific Corp — WATCHMAN FLX Pro Left Atrial Appendage Closure Device with Delivery System (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Feb 12, 2026device pma164d 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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Feb 12, 2026device pma164d 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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Feb 12, 2026device pma164d agoAbbott Laboratories — ARCHITECT AFP; Alinity i AFP (LN 3P36/07P90) (PMA supplement)ABBOTT LABORATORIES

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

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Feb 12, 2026device pma164d agoBiotronik, Inc. — Solia CSP S 53; Solia CSP S 60 (PMA supplement)

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

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Feb 12, 2026device pma164d agoMedtronic, Inc. — Hancock II Bioprosthesis (PMA supplement)Medtronic plc

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

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Feb 12, 2026device pma164d agoMedtronic Neuromodulation — SNS Urinary Neurostimulator Models 97800, 97810; SNS Urinary Screening Trialing Systems Model 3531 (PMA supplement)

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

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Feb 12, 2026device pma164d agoMedtronic Neuromodulation — SNS Bowel Neurostimulator Models 97800, 97810; SNS Bowel Screening Trialing System Model 3531 (PMA supplement)

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

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Feb 12, 2026device pma164d agoMedtronic, Inc. — DBS Implantable Neurostimulator Models B35200, B35300; DBS Implantable Neurostimulators Activa Family Models 37601, 3760 (PMA supplement)Medtronic plc

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

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Feb 12, 2026device pma164d agoMedtronic Neuromodulation — Altaviva Model P7850N (PMA supplement)

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

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Feb 12, 2026device pma164d agoMedtronic, Inc. — Consulta CRT-P C4TR01 Syncra CRT-P C2TR01 (PMA supplement)Medtronic plc

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

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Feb 12, 2026device pma164d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D DTMB1D1, DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D1, DTBC1D4 Brava Quad CRT-D D (PMA supplement)

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

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Feb 12, 2026device pma164d agoInstylla, Inc. — Embrace Hydrogel Embolic System (HES) (PMA supplement)

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

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Feb 12, 2026device pma164d agoPhilips Image Guided Therapy Corporation — Duo Venous Stent System (PMA supplement)

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

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Feb 12, 2026device pma164d agoEdwards Lifesciences, LLC — Edwards Commander Delivery System (9600LDS20, 9600LDS23, 9600LDS26, 9600LDS29, 9750CM20, 9750CM23, 9750CM26) (PMA supplement)Edwards Lifesciences Corp

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

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Feb 12, 2026device pma164d agoEdwards Lifesciences, LLC — Edwards EVOQUE Tricuspid Valve Replacement System (9850TDS) (PMA supplement)Edwards Lifesciences Corp

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

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Feb 12, 2026device pma164d agoMedtronic Neuromodulation — External Neurostimulator (ENS) Model 97725; Intellis Model 97716; Intellis Model 97715; SCS Implantable Neurostimulator (PMA supplement)

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

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Feb 12, 2026device pma164d agoMedtronic Cardiac Rhythm Disease Management — Evera MRI DF-1 ICD DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1 Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DD (PMA supplement)

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

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Feb 12, 2026device pma164d agoABBOTT MEDICAL — Amplatzer Piccolo Occluder (PMA supplement)

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

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Feb 12, 2026device pma164d agoMedtronic, Inc. — Drug Delivery Infusion Pump Model 8667 (PMA supplement)Medtronic plc

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

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Feb 12, 2026device pma164d agoMedtronic, Inc. — Evolut PRO, PRO+, FX, FX+ (PMA supplement)Medtronic plc

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

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Feb 12, 2026device pma164d agoBiosense Webster, Inc. — VARIPULSE Platform (VARIPULSE Catheter; TRUPULSE Generator; Sterile Interface Cable; nGEN Pump) (PMA supplement)

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

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Feb 12, 2026device pma164d agoMedtronic, Inc. — Freestyle Bioprosthesis (PMA supplement)Medtronic plc

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

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Feb 12, 2026device pma164d agoAbbott Laboratories — ARCHITECT Free PSA; Alinity i Free PSA (LN 6C07/07P93) (PMA supplement)ABBOTT LABORATORIES

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

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Feb 12, 2026device pma164d agoMedtronic, Inc. — Harmony Transcatheter Pulmonary Valve (PMA supplement)Medtronic plc

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

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Feb 12, 2026device pma164d agoBecton, Dickinson and Company — BD FOX PCR Extraction Tubes; BD Onclarity HPV Assay (PMA supplement)BECTON DICKINSON & CO

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

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Feb 12, 2026device pma164d agoEmpirical Spine, Inc. — LimiFlex Dynamic Sagittal Tether (PMA)

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

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Feb 12, 2026device pma164d agoDepuy, Inc. — LCS® Total Knee System (PMA supplement)

Supplement type: Special (Immediate Track). Product code: NJL. Advisory committee: OR. Decision: APPR

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Feb 12, 2026device pma164d agoMedtronic, Inc. — Advisa DR IPG A4DR01 Advisa DR MRI IPG A2DR01 Advisa SR MRI IPG A3SR01 (PMA supplement)Medtronic plc

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

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Feb 12, 2026device pma164d agoMedtronic, Inc. — Mosaic Bioprosthesis (PMA supplement)Medtronic plc

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

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Feb 13, 2026device pma163d agoBoston Scientific Corp — ACUITY X4 Straight/ model 4671; ACUITY X4 Straight/ model 4672; ACUITY X4 Spiral S/ model 4674; ACUITY X4 Spiral S/ mod (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Feb 13, 2026device pma163d agoBoston Scientific — RELIANCE 4-FRONT/model 0636; RELIANCE 4-FRONT/ model 0662; RELIANCE 4-FRONT/ model 0663 00802526592805 P910073; RELIANC (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Feb 13, 2026device pma163d agoMedtronic, Inc. — Sprint Quattro Lead (6935M, 6947); Sprint Quattro Lead (6935, 6947M) (PMA supplement)Medtronic plc

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

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Feb 13, 2026device pma163d agoMedtronic Sofamor Danek USA, Inc. — Infuse Bone Graft (PMA supplement)Medtronic USA Inc

Supplement type: Panel Track. Product code: NEK. Advisory committee: OR. Decision: APPR

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Feb 13, 2026device pma163d agoEndotronix, Inc. — Cordella Pulmonary Artery Sensor System (CorPASS) (PMA supplement)

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

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Feb 13, 2026device pma163d agoMedtronic Vascular, Inc. — IN.PACT AV Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (PMA supplement)DFB Soria LLC

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

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Feb 13, 2026device pma163d agoABBOTT MEDICAL — Avant (CDHFA700Q, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800T CDHFA600Q, CDHFA600T); Gallant (CDHFA500Q, CDHFA500T); (PMA supplement)

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

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Feb 13, 2026device pma163d agoABBOTT MEDICAL — Avant (CDVRA700Q, CDVRA700T); Neutrino NxT (CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T); Gallant (CDVRA500Q, CDVRA500T); (PMA supplement)

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

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Feb 13, 2026device pma163d agoDepuy, Inc. — LCS® Total Knee System (PMA supplement)

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

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Feb 13, 2026device pma163d agoDepuy, Inc. — LCS® Total Knee System (PMA supplement)

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

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Feb 13, 2026device pma163d agoMedtronic, Inc. — IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (PMA supplement)Medtronic plc

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

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Feb 13, 2026device pma163d agoBoston Scientific — INGEVITY MRI/ model 7731; INGEVITY MRI/ model 7732; INGEVITY MRI/ model 7735; INGEVITY MRI/ model 7736; INGEVITY MR (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Week of Feb 9, 2026