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 →
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| PMA | P030017 | Stimulator, spinal-cord, totally implanted for pain relief | LGW | 2026-08-10 | View |
| PMA | P150031 | Stimulator, electrical, implanted, for parkinsonian symptoms | NHL | 2026-08-10 | View |
| PMA | P110035 | STENT, ILIAC | NIO | 2026-08-06 | View |
| PMA | P180011 | Stent, superficial femoral artery, drug-eluting | NIU | 2026-08-06 | View |
| PMA | P010012 | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) | NIK | 2026-07-23 | View |
| PMA | N970003 | Implantable pulse generator, pacemaker (non-CRT) | LWP | 2026-07-23 | View |
| PMA | P130013 | System, appendage closure, left atrial | NGV | 2026-07-21 | View |
| PMA | N970012 | Prosthesis, penis, inflatable | JCW | 2026-05-18 | View |
| PMA | P900056 | CATHETER, CORONARY, ATHERECTOMY | MCX | 2026-05-06 | View |
| PMA | P130030 | STENT, CORONARY | MAF | 2026-03-10 | View |
| PMA | P000053 | Device, incontinence, mechanical/hydraulic | EZY | 2026-02-25 | View |
| PMA | P950020 | Catheter, percutaneous transluminal coronary angioplasty (ptca), cutting/scoring | NWX | 2026-01-27 | View |
| PMA | P150005 | catheter, percutaneous, cardiac ablation, for treatment of atrial flutter | OAD | 2025-12-05 | View |
| PMA | P920047 | Cardiac ablation percutaneous catheter | LPB | 2025-10-17 | View |
| PMA | P050019 | Stent, carotid | NIM | 2025-09-19 | View |
| PMA | P980037 | CATHETER, CORONARY, ATHERECTOMY | MCX | 2025-08-01 | View |
| PMA | P110010 | Coronary drug-eluting stent | NIQ | 2025-01-14 | View |
| 510(k) | K243245 | IceSeed 1.5 CX Straight Needle (H7493968333170); IceSphere1.5 CX Straight Needle (H7493968435730); IceRod 1.5 CX Straight Needle (H7493968535330) | GEH | 2024-10-18 | View |
| PMA | P930031 | SHUNT, PORTOSYSTEMIC, ENDOPROSTHESIS | MIR | 2024-06-27 | View |
| PMA | P980003 | Cardiac ablation percutaneous catheter | LPB | 2023-12-12 | View |
No matching devices.
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