MAGIC WALLSTENT ENDOPROSTHESIS AND RADIUS CORONARY STENT WITH DELIVERY SYSTEM
FDA premarket approval P970061/S013 · decided 2002-01-22
Approval details
- PMA number
- P970061
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Express GMP Supplement
- Trade name
- MAGIC WALLSTENT ENDOPROSTHESIS AND RADIUS CORONARY STENT WITH DELIVERY SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Boston Scientific Scimed, Inc.
- Date received
- 2001-12-07
- Decision date
- 2002-01-22
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL FOR TWO ALTERNATE MANUFACTURING FACILITIES FOR PACKAGING AND LABELING OPERATIONS LOCATED AT BOSTON SCIENTIFIC CORPORATION, QUINCY, MASSACHUSETTS AND BOSTON SCIENTIFIC EUROPEAN DISTRIBUTION CENTER, BEEK, THE NETHERLANDS.
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 |