RADIUS CORONARY STENT WITH SINGLE-OPERATOR EXCHANGE (SOE) DELIVERY SYSTEM
FDA premarket approval P970061/S012 · decided 2001-11-29
Approval details
- PMA number
- P970061
- Supplement
- S012
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- RADIUS CORONARY STENT WITH SINGLE-OPERATOR EXCHANGE (SOE) DELIVERY SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Boston Scientific Scimed, Inc.
- Date received
- 2001-10-09
- Decision date
- 2001-11-29
- Days to decision
- 51 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR AN ADDITIONAL MANUFACTURING FACILITY LOCATED AT BOSTON SCIENTIFIC IRELAND, LTD, GALWAY, IRELAND AND AN ADDITIONAL STERILIZATION FACILITY LOCATED AT ISOTRON, OFFALY, IRELAND.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| MODIFICATION TO ATLANTIS PV IMAGING CATHETER, MODEL 36456 (K041727) | Boston Scientific Scimed, Inc. | 2004-07-23 |
| PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE (K030617) | Boston Scientific Scimed, Inc. | 2003-05-21 |
| MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM (K024048) | Boston Scientific Scimed, Inc. | 2003-01-06 |
| BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER (K021735) | Boston Scientific Scimed, Inc. | 2002-08-08 |
| WALLGRAFT TRACHEOBRONCHIAL ENDOPROTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (K021901) | Boston Scientific Scimed, Inc. | 2002-07-09 |
| MODIFICIATION TO: BILIARY WALLSTENT ENDOPROSTHEIS WITH MONORAIL DELIVERY SYSTEM, MODEL 71-XXX (K012822) | Boston Scientific Scimed, Inc. | 2001-10-24 |
| NIROYAL BILIARY PREMOUNTED STENT SYSTEM (K012216) | Boston Scientific Scimed, Inc. | 2001-08-17 |
| BOSTON SCIENTIFIC SCIMED ATLANTIS CORONARY IMAGING CATHETER, MODEL C4020 (K000743) | Boston Scientific Scimed, Inc. | 2000-09-06 |