BIODIVYSIO SV OTW PHOSPHORYLCHOLINE COATED STENT DELIVERY SYSTEM
FDA premarket approval P000011/S006 · decided 2002-07-26
Approval details
- PMA number
- P000011
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Trade name
- BIODIVYSIO SV OTW PHOSPHORYLCHOLINE COATED STENT DELIVERY SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2002-02-01
- Decision date
- 2002-07-26
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE ADDITION OF THE 7 MM STENT LENGTH (IN ALL DIAMETERS, 2.0, 2.25 AND 2.5 MM) AND 2.25 MM DIAMETER BIODIVYSIO SV OTW PRODUCT TO PREVIOUSLY APPROVED STENT LENGTHS OF 10, 15 AND 18 MM (SUPPLEMENT 3). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIODIVYSIO 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 REST
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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 |