VERIFLEX FOR LIBERTE BARE METAL STENTS
FDA premarket approval P040016/S037 · decided 2009-09-25
Approval details
- PMA number
- P040016
- Supplement
- S037
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- VERIFLEX FOR LIBERTE BARE METAL STENTS
- Generic name
- STENT, CORONARY
- Applicant
- Boston Scientific Scimed, Inc.
- Date received
- 2009-09-15
- Decision date
- 2009-09-25
- Days to decision
- 10 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Maple Grove, MN
- Statement
- APPROVAL TO ADD AN ALTERNATE TRADE NAME FOR THE LIBERTÉ MONORAIL AND OVER-THE-WIRE CORONARY STENT SYSTEMS. THE DEVICE WILL BE MARKETED UNDER THE TRADE NAME VERIFLEX BARE METAL CORONARY STENT AND IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE WITH STENOTIC LESIONS IN NATIVE CORONARY ARTERIES (LENGTH <28 MM) WITH A REFERENCE VESSEL DIAMETER OF 2.75 TO 5.00 MM.
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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 |