Calendar

Week of Feb 9, 2026

Feb 10, 2026device pma184d agoContamac, Ltd. — Optimum Infinite (tisilfocon A) Orthokeratology Lenses II (PMA)

Product code: NUU. Advisory committee: OP. Decision: APPR

Feb 10, 2026device pma184d agoMedtronic Cardiac Rhythm Disease Management — CapSure Sense Lead 4574 CapSure Sense Lead 4073, 4074 Vitatron Crystalline Lead ICM09, ICM09B, ICM09JB Vitatron Excellen (PMA supplement)

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

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Feb 10, 2026device pma184d agoABBOTT MEDICAL — Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) (PMA supplement)

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

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Feb 10, 2026device pma184d agoCooperVision, Inc. — Biofinity Sphere and 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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Feb 10, 2026device pma184d agoAbbott Vascular, Inc. — Perclose ProGlide Suture-Mediated Closure System; Perclose ProStyle Suture-Mediated Closure and Repair System (PMA supplement)

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

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Feb 10, 2026device pma184d agoABBOTT MEDICAL — Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) (PMA supplement)

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

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Feb 10, 2026device pma184d agoMedtronic, Inc. — Consulta CRT-P (C4TR01); Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1T (PMA supplement)Medtronic plc

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

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Feb 10, 2026device pma184d agoMedtronic, Inc. — CapSure Epicardial Pacing Lead (4965); CapSure Epicardial Pacing Lead (4968) (PMA supplement)Medtronic plc

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

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Feb 10, 2026device pma184d agoMedtronic, Inc. — HV Splitter/Adaptor kit 5019 IS-1 Connector Port Pin Plug Kit 6725 Sprint Quattro Lead 6935, 6947 Sprint Quattro Lead 69 (PMA supplement)Medtronic plc

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

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Feb 10, 2026device pma184d agoMedtronic, Inc. — Adapta, Versa, Sensia IPG (ADDR01, ADDR03, ADDR06, ADDRL1, ADSR03, ADVDD01, SED01, SES01, VEDR01); Adapta, Versa, Sensia (PMA supplement)Medtronic plc

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

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Feb 10, 2026device pma184d agoMedtronic, Inc. — Attain OTW LV Lead; Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Qua (PMA supplement)Medtronic plc

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

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Feb 10, 2026device pma184d agoMedtronic, Inc. — Attain StarFix Lead (PMA supplement)Medtronic plc

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

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Feb 10, 2026device pma184d agoMedtronic, Inc. — Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve; Medtronic Evolut PRO+ Transcatheter Aortic Valve; Medtroni (PMA supplement)Medtronic plc

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

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Feb 10, 2026device pma184d agoAlcon Research, LLC — UNIPURE SF6 Ophthalmic Gas in the UNIFEYE Gas Delivery System (PMA supplement)

Supplement type: Real-Time Process. Product code: LPO. Advisory committee: OP. Decision: APPR

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Feb 10, 2026device pma184d agoMedtronic, Inc. — CapSureFix Novus Lead (5076); CapSureFix Novus Lead (4076); Vitatron Crystalline ActFix Lead (ICF09B); Vitatron Crystall (PMA supplement)Medtronic plc

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

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Feb 10, 2026device pma184d agoMedtronic, Inc. — CapSure VDD-2 Lead 5038, 5038L, 5038S Service Kit-Pacemaker Repair Kit 5873C Vitatron Brilliant S+ VDD Lead IMW14Q, IMW1 (PMA supplement)Medtronic plc

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

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Feb 10, 2026device pma184d agoMedtronic Cardiac Rhythm Disease Management — CapSure SP Novus Lead 5092 CapSure SP Z Lead 5033 Vitatron Impulse II Lead IHP09, IHP09B, IHP09JB (PMA supplement)

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

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Feb 10, 2026device recall184d agoOrthalign, Inc device recall (Cls II)

Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System — Reason: Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) — Status: Ongoing

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Feb 10, 2026device recall184d agoOrthalign, Inc device recall (Cls II)

Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System — Reason: Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) — Status: Ongoing

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Feb 10, 2026device recall184d agoLeMaitre Vascular, Inc. device recall (Cls II)LEMAITRE VASCULAR INC

Artegraft Vascular Graft; REF#: AG740; — Reason: Labeling mix-up resulting in the incorrect lot outer packaging of product. — Status: Ongoing

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Feb 10, 2026device recall184d agoBoston Scientific Corporation device recall (Cls II)BOSTON SCIENTIFIC CORP

EndoVive Safety PEG Kit; Outer Box Material Number (UPN): M00509001; Inner Box Material Number (UPN): M00509000; — Reason: Recall of kits which utilized ChloraPrep Triple Swabsticks from BD. Open or compromised seals on the sterile swabstick packaging, which could result in loss of sterility or drying of the antiseptic solution. This component is placed outside of the sterile barrier of the tray manufactured by Boston Scientific, which contains the majority of the kit components. As such, inclusion of the affected ChloraPrep Triple Swabsticks does not degrade the integrity of the other components within the PEG kit. — Status: Ongoing

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Feb 10, 2026device recall184d agoMedline Industries, LP device recall (Cls II)

Puracol and Puracol Plus Collagen Wound Dressings: MSC8522 DRESSING,COLLAGEN,PURACOL,STRL,2" X 2" MSC8622EP DRESSING,COLLAGEN,PURACOL PLUS, 2X2.2" — Reason: Elevated endotoxin levels identified in affected lots. Issue may elicit strong inflammatory response if used, including local tissue irritation, delayed wound healing, or systemic effects such as fever and hypotension. In severe cases, septic shock may result. — Status: Ongoing

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Feb 10, 2026grant184d agoNORTH DAKOTA STATE UNIVERSITY — Targeting CLEC-2/podoplanin as a therapeutic strategy for pancreatic cancer

GM grant. $224,737. PI: Elisabetta Liverani

Week of Feb 9, 2026