Calendar

pharmadog

Week of Feb 2, 2026

Feb 4, 2026device 510k190d agoEvolution Spine — E3D-C Interbody System (510k cleared)

Product code: OVE. Advisory committee: Orthopedic. Type: Special

full page →fda device 510k ↗

Feb 4, 2026device pma190d agoInstylla, Inc. — Embrace Hydrogel Embolic System (PMA supplement)

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

full page →fda device pma ↗

Feb 4, 2026device pma190d agoMedinol, Ltd. — EluNIR Ridaforolimus Eluting Coronary Stent System (PMA supplement)IGC Pharma, Inc.

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

full page →fda device pma ↗

Feb 4, 2026device pma190d agoMentor Corp. — MENTOR MemoryGel Breast Implants (PMA supplement)

Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗

Feb 4, 2026device pma190d agoMentor Worldwide, LLC — MENTOR MemoryShape Breast Implants (PMA supplement)

Supplement type: 30-Day Notice. Product code: FTR. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗

Feb 4, 2026device pma190d agoMentor Worldwide, LLC — MENTOR Saline-Filled and SPECTRUM Breast Implants (PMA supplement)Revalesio Corp

Supplement type: 30-Day Notice. Product code: FWM. Advisory committee: SU. Decision: OK30

full page →fda device pma ↗

Feb 4, 2026device pma190d agoGuardant Health, Inc. — Shield (PMA supplement)Guardant Health, Inc.

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

full page →fda device pma ↗

Feb 4, 2026device pma190d agoMedtronic, Inc. — Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve (EVOLUTPRO-23-US, EVOLUTPRO-26-US, EVOLUTPRO-29-US); Medtron (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Feb 4, 2026device pma190d agoABBOTT MEDICAL — HeartMate 3 Left Ventricular Assist System (PMA supplement)

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

full page →fda device pma ↗

Feb 4, 2026device pma190d agoMedtronic, Inc. — Avalus Bioprosthesis Model 400 (40019, 40021, 40023, 40025, 40027, 40029); Avalus Ultra Bioprosthesis Model 400 (400U1 (PMA supplement)Medtronic plc

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

full page →fda device pma ↗

Feb 4, 2026device recall190d agoDiagnostica Stago, Inc. device recall (Cls II)

Brand Name: STA Liatest Free Protein S Product Name: STA Liatest Free Protein S Model/Catalog Number (REF): 00516 Product Description: The STA¿ - Liatest¿ Free Protein S kits are intended for use on STA-R¿ and STA Compact¿ for the quantitative antigenic assay of free protein S in human citrated plasma by the immuno-turbidimetric method. Component: Not Applicable — Reason: The potential of out-of-range results and an underestimation of the free protein S level in normal patient plasmas. The defect only affects normal-range values. — Status: Ongoing

full page →fda device recalls ↗

Feb 4, 2026grant190d agoUNIVERSITY OF CALIFORNIA, SAN DIEGO — Discovery and evolution of mammalian Serpins as host-encoded viral protease i...University of California San Diego

AI grant. $439,250. PI: Matthew Daugherty

Week of Feb 2, 2026