SCIMED RADIUS CORONARY STENT WITH SINGLE-OPERATOR EXCHANGE DELIVERY SYSTEM
FDA premarket approval P970061/S005 · decided 1999-02-11
Approval details
- PMA number
- P970061
- Supplement
- S005
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SCIMED RADIUS CORONARY STENT WITH SINGLE-OPERATOR EXCHANGE DELIVERY SYSTEM
- Applicant
- Boston Scientific Scimed, Inc.
- Date received
- 1998-09-08
- Decision date
- 1999-02-11
- Days to decision
- 156 days
- Decision code
- APPR
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- Approval for a Single-Operator Exchange (SOE) Delivery System for the SCIMED(R) RADIUS(TM) Stent. The device, as modified, will be marketed under the trade name SCIMED(R) RADUS(TM) Coronary Stent with Single-Operator Exchange (SOE) Delivery System and is indicated for use in pateitns with symptomatic ischemic heart disease due to discrete de novo native coronary artery and saphenous vein bypass graft lesions (length <30mm) with reference vessel diameter ranging from 2.75 to 4.25mm and is intende
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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 |