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calendar

19 catalysts · 16,260 approval · 2,184 device 510k · 433 recall · 19 device pma

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type: device pma×to 2025-05-29×clear all
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  • approval16,260
  • device 510k2,184
  • recall433
  • device pma19
therapy area

no tagged catalysts yet

Week of May 26, 2025

19
›
May 28, 2025
device pma
445d ago
Boston Scientific Corp — AMS 700™ Inflatable Penile Prosthesis without InhibiZone™ (PMA supplement)BOSTON SCIENTIFIC CORP

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

full page →fda device pma ↗
›May 28, 2025device pma445d agoVistakon, Division of Johnson & Johnson Vision Car — VISTAKON® (senofilcon A) Brand Contact Lenses (PMA supplement)JOHNSON & JOHNSON

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

full page →fda device pma ↗
›May 28, 2025device pma445d agoCerenovus, Inc. — TRUFILL n-BCA Liquid Embolic System (LES) and Procedural Set (PMA supplement)

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

full page →fda device pma ↗
›May 28, 2025device pma445d agoFerring Pharmaceuticals, Inc. — EUFLEXXA (1% SODIUM HYALURONATE) (PMA supplement)Ferring Pharmaceuticals Inc

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

full page →fda device pma ↗
›May 28, 2025device pma445d agoColoplast Corp. — Titan Inflatable Penile Prosthesis (PMA supplement)

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

full page →fda device pma ↗
›May 28, 2025device pma445d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI CRT-D DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ; Cobalt XT MRI CRT-D DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ; Crome MRI C (PMA supplement)

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

full page →fda device pma ↗
›May 28, 2025device pma445d agoMedtronic Cardiac Rhythm Disease Management — Cobalt MRI ICD DVPB3D1, DVPB3D4; Cobalt MRI ICD DDPB3D1, DDPB3D4; Cobalt XT MRI ICD DDPA2D1, DVPA2D1; Cobalt XT MRI ICD (PMA supplement)

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

full page →fda device pma ↗
›May 28, 2025device pma445d agoBoston Scientific Corp — AMS 800™ Artificial Urinary Sphincter (AUS) (PMA supplement)BOSTON SCIENTIFIC CORP

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

full page →fda device pma ↗
›May 28, 2025device pma445d agoCordis US Corporation — S.M.A.R.T. AND S.M.A.R.T. CONTROL NITINOL STENT SYSTEM (PMA supplement)

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

full page →fda device pma ↗
›May 28, 2025device pma445d agoIrvine Biomedical, Inc. — IBI THERAPY COOL PATH ABLATION CATHETER & IBI-1500T9 RF (PMA supplement)RNR BioMedical Inc

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

full page →fda device pma ↗
›May 28, 2025device pma445d 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

full page →fda device pma ↗
›May 29, 2025device pma444d agoPremia Spine, Ltd. — TOPS™ System (PMA supplement)

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

full page →fda device pma ↗
›May 29, 2025device pma444d agoNuvasive, Inc. — Simplify® Cervical Artificial Disc (PMA supplement)

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

full page →fda device pma ↗
›May 29, 2025device pma444d 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

full page →fda device pma ↗
›May 29, 2025device pma444d agoMedtronic, Inc. — IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C (PMA supplement)Medtronic plc

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

full page →fda device pma ↗
›May 29, 2025device pma444d agoPramand, LLC — CraniSeal Dural Sealant (PMA supplement)

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

full page →fda device pma ↗
›May 29, 2025device pma444d agoOrbusNeich Medical (Shenzhen) Co., Ltd. — Scoreflex NC Scoring PTCA Catheter (PMA supplement)

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

full page →fda device pma ↗
›May 29, 2025device pma444d agoJohnson & Johnson Surgical Vision, Inc. — Intraocular Lenses (IOLs) in the DaisyWheel and TECNIS SIMPLICITY Delivery System (PMA supplement)JOHNSON & JOHNSON

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

full page →fda device pma ↗
›May 29, 2025device pma444d agoBoston Scientific Corp — VERCISE DEEP BRAIN STIMULATION (DBS)SYSTEM (PMA supplement)BOSTON SCIENTIFIC CORP

Supplement type: Special (Immediate Track). Product code: NHL. Advisory committee: NE. Decision: APPR

full page →fda device pma ↗
$BSX51.83+0.27%
$MDT91.27+0.76%
$BSX51.83+0.27%
$JNJ260.35-0.66%
$BSX51.83+0.27%
$JNJ260.35-0.66%
$BSX51.83+0.27%