PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIOH SV STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYST SV OTW), AND PC C)
FDA premarket approval P000011/S003 · decided 2001-12-21
Approval details
- PMA number
- P000011
- Supplement
- S003
- Supplement type
- Normal 180 Day Track
- Trade name
- PHOSPHORYLCHOLINE (PC) COATED BIODIVYSIOH SV STENT PREMOUNTED ON AN OVER-THE-WIRE (OTW) DELIVERY SYST SV OTW), AND PC C)
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2001-06-28
- Decision date
- 2001-12-21
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR: 1) THE BIODIVYSIO(TM) SV OTW IN 10 MM, 15 MM AND 18 MM STENT LENGTHS AND 2.0 MM AND 2.5 MM DIAMETERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIODIVYSIO(TM) SV OTW AND IS INDICATED FOR "IMPROVING CORONARY LUMINAL DIAMETER IN SUBJECTS EXPERIENCING ABRUPT CLOSURE OR THREATENED ABRUPT VESSEL CLOSURE FOLLOWING PERCUTANEOUS REVASCULARIZATION OF DE NOVO OR NON IN-STENT RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH OF LESION AND/OR DISSECTION <=25 MM) WITH A REF
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510(k) clearances by this applicant
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| HI-TORQUE COMMAND GUIDE WIRE FAMILY (K122573) | Abbott Vascular, Inc. | 2012-11-20 |
| ARMADA 14 PTA CATHETER (K102705) | Abbott Vascular, Inc. | 2010-12-07 |
| HI-TORQUE WINN GUIDE WIRE FAMILY (K101648) | Abbott Vascular, Inc. | 2010-07-08 |
| HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL (K101011) | Abbott Vascular, Inc. | 2010-05-24 |
| HI-TORQUE PROGRESS GUIDE WIRE FAMILY (K091825) | Abbott Vascular, Inc. | 2009-09-25 |
| FOXCROSS PTA CATHETER (K081417) | Abbott Vascular, Inc. | 2008-06-04 |