MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT
FDA premarket approval P980009/S002 · decided 1999-07-28
Approval details
- PMA number
- P980009
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MAGIC WALLSTENT SELF-EXPANDING CORONARY STENT
- Generic name
- STENT, CORONARY
- Applicant
- Boston Scientific Scimed, Inc.
- Date received
- 1998-12-28
- Decision date
- 1999-07-28
- Days to decision
- 212 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- Yes
- Location
- Maple Grove, MN
- Statement
- Approval to add an indication for the treatment of saphenous vein grafts. The device is now indicated for improving luminal diameter in the following: 1)pts w/symptomatic ischemic disease due to discrete de novo lesion in native coronary arteries (length < 35 mm) wiht a reference vessel diameter of 3.0 to 5.5 mm; 2) treatment of abrupt or threatened closure in patients with failed interventional therapy in lesions with reference diameters in the range of 3.0 to 5.5 mm. 3) Patients with symptomat
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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 |