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Boston Scientific Corp

FDA 510(k) & PMA Approved Devices — 25 products

Total Devices25
Categories22
Latest FDA decision2026-08-10

SEC Filings: 1 filings on record. Latest: 8-K (2026-07-29). View on SEC EDGAR →

TypeNumberDevice NameCodeDateActions
PMA P030017 Stimulator, spinal-cord, totally implanted for pain reliefLGW2026-08-10 View
PMA P150031 Stimulator, electrical, implanted, for parkinsonian symptomsNHL2026-08-10 View
PMA P110035 STENT, ILIACNIO2026-08-06 View
PMA P180011 Stent, superficial femoral artery, drug-elutingNIU2026-08-06 View
PMA P010012 Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)NIK2026-07-23 View
PMA N970003 Implantable pulse generator, pacemaker (non-CRT)LWP2026-07-23 View
PMA P130013 System, appendage closure, left atrialNGV2026-07-21 View
PMA N970012 Prosthesis, penis, inflatableJCW2026-05-18 View
PMA P900056 CATHETER, CORONARY, ATHERECTOMYMCX2026-05-06 View
PMA P130030 STENT, CORONARYMAF2026-03-10 View
PMA P000053 Device, incontinence, mechanical/hydraulicEZY2026-02-25 View
PMA P950020 Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoringNWX2026-01-27 View
PMA P150005 catheter, percutaneous, cardiac ablation, for treatment of atrial flutterOAD2025-12-05 View
PMA P920047 Cardiac ablation percutaneous catheterLPB2025-10-17 View
PMA P050019 Stent, carotidNIM2025-09-19 View
PMA P980037 CATHETER, CORONARY, ATHERECTOMYMCX2025-08-01 View
PMA P110010 Coronary drug-eluting stentNIQ2025-01-14 View
510(k) K243245 IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330)GEH2024-10-18 View
PMA P930031 SHUNT, PORTOSYSTEMIC, ENDOPROSTHESISMIR2024-06-27 View
PMA P980003 Cardiac ablation percutaneous catheterLPB2023-12-12 View

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