Calendar

pharmadog

Week of Mar 2, 2026

Mar 4, 2026device pma164d agoLivaNova USA, Inc. — VNS Therapy® System (PMA supplement)

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

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Mar 4, 2026device pma164d 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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Mar 4, 2026device pma164d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D (DTPB2Dl, DTPB2D4, DTPB2Ql, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2Dl, DTPA2D4, DTPA2Ql, DTPA2QQ); Crome M (PMA supplement)

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

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Mar 4, 2026device pma164d agoElement Science, Inc. — Jewel Patch Wearable Cardioverter Defibrillator (P-WCD) (Jewel); Jewel P-WCD Firmware; Jewel Placement Accessory (Class (PMA supplement)

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

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Mar 4, 2026device pma164d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD (DDPB3Dl, DDPB3D4, DVPB3Dl, DVPB3D4); Cobalt XT MRI ICD (DDPA2Dl, DDPA2D4, DVPA2Dl, DVPA2D4); Crome MRI I (PMA supplement)

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

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Mar 4, 2026device pma164d agoSTAAR Surgical Company — The EVO/EVO+ Visian Implantable Collamer Lens (ICL) (PMA supplement)STAAR SURGICAL CO

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

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Mar 4, 2026device pma164d agoLife Technologies Corporation — Oncomine Dx Target Test (PMA supplement)

Supplement type: Special (Immediate Track). Product code: PQP. Advisory committee: PA. Decision: APPR

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Mar 4, 2026device pma164d 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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Mar 4, 2026device pma164d agoCooperVision, Inc. — Biofinity Toric (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (PMA supplement)

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

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Mar 4, 2026device pma164d agoCooperVision, Inc. — Biofinity Toric Multifocal (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear (PMA supplement)

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

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Mar 5, 2026device pma163d agoBiotronik, Inc. — Acticor Sky VR-T (481989); Rivacor Sky VR-T (481984); Rivacor Rise VR-T (482020); Rivacor Aura VR-T (482015); Acticor Sk (PMA supplement)

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

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Mar 5, 2026device pma163d agoShockwave Medical, Inc. — Shockwave lntravascular Lithotripsy (IVL) System with Shockwave C2 Aero Coronary IVL Catheter (PMA supplement)

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

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Mar 5, 2026device pma163d agoBoston Scientific Corp — ROTAPRO Rotational Atherectomy System (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Mar 5, 2026device pma163d agoBiotronik, Inc. — Edora 8 DR-T (407145); Evity 8 DR-T (407146); Enitra 8 DR-T (407147); Enticos 8 DR-T (407148); Evity 6 DR-T (407149); En (PMA supplement)

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

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Mar 5, 2026device pma163d agoInsightec — Exablate Model 4000 Type 1.0 and 1.1 (Exablate Neuro; Exablate Prime) (PMA supplement)

Supplement type: Real-Time Process. Product code: POH. Advisory committee: NE. Decision: APPR

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Mar 5, 2026device pma163d 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 (4 (PMA supplement)

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

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Mar 5, 2026device pma163d 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 (4071 (PMA supplement)

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

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Mar 5, 2026device pma163d agoHologic, Inc. — Rapid fFN for the TLiIQ System (PMA supplement)

Supplement type: 30-Day Notice. Product code: LKV. Advisory committee: TX. Decision: OK30

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Mar 5, 2026device pma163d agoHologic, Inc. — Rapid fFN for the TLiIQ System (PMA supplement)

Supplement type: 30-Day Notice. Product code: LKV. Advisory committee: TX. Decision: OK30

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Mar 5, 2026device pma163d agoPhysio-Control, Inc. — LIFEPAK 35 monitor/defibrillator (PMA supplement)

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

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Mar 6, 2026device pma162d agoKestra Medical Technologies, Inc. — ASSURE Wearable Cardioverter Defibrillator (WCD) System (PMA supplement)KESTRA MEDICAL TECHNOLOGIES, LTD.

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

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Mar 6, 2026device pma162d agoEuclid Vision Corporation — Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear, Euclid Orthokeratology (tisilfocon A) Contact Le (PMA supplement)

Supplement type: Normal 180 Day Track. Product code: NUU. Advisory committee: OP. Decision: APPR

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Mar 6, 2026device pma162d agoMedtronic, Inc. — HV Splitter/ Adaptor kit (PMA supplement)Medtronic plc

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

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Mar 6, 2026device pma162d agoBiomet Manufacturing Corp — Oxford Cementless Partial Knee System (PMA supplement)

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

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Mar 6, 2026device pma162d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR I CD; Ev (PMA supplement)

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

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Mar 6, 2026device pma162d agoABBOTT MEDICAL — TriClip G4 System (PMA supplement)

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

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Mar 6, 2026device pma162d agoMedtronic Cardiac Rhythm Disease Management — SelectSecure Lead (PMA supplement)

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

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Mar 6, 2026device pma162d agoMedtronic, Inc. — IN.PACT 018 Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (PMA supplement)Medtronic plc

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

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Mar 6, 2026device pma162d agoBoston Scientific — ENDOTAK RELIANCE / RELIANCE 4-FRONT pace/sense defibrillation leads (PMA supplement)BOSTON SCIENTIFIC CORP

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

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Mar 6, 2026device pma162d agoMedtronic, Inc. — Harmony TPV System (PMA supplement)Medtronic plc

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

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Mar 6, 2026device pma162d agoTMJ Concepts — TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis (PMA supplement)

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

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Mar 6, 2026device pma162d agoMedtronic, Inc. — Aurora EV ICD; Epsila EV Extravascular Lead (PMA supplement)Medtronic plc

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

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Mar 6, 2026device pma162d agoW. L. Gore & Associates, Inc. — GORE® VIABAHN® FORTEGRA Venous Stent (PMA supplement)

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

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Mar 6, 2026device pma162d agoABBOTT MEDICAL — MitraClip NTR/XTR Clip Delivery System; MitraClip G4 System (PMA supplement)

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

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Mar 6, 2026device pma162d agoBioventus, LLC — SONIC ACCELERATED FRACTURE HEALING SYSTEM MODEL 2A (PMA supplement)Bioventus Inc.

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

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Mar 6, 2026device pma162d agoMedtronic Cardiac Rhythm Disease Management — Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt (PMA supplement)

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

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Mar 6, 2026device pma162d agoMedtronic, Inc. — Percepta Bipolar CRT-P; 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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Mar 6, 2026device pma162d 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 9, 2026

Mar 9, 2026device pma159d agoCook, Inc. — Zenith Flex AAA Endovascular System and Zenith Iliac Branch (PMA supplement)

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

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Mar 9, 2026device pma

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