BIODIVYSIO OC/OTW STENT SYSTEM
FDA premarket approval P000011/S004 · decided 2002-03-01
Approval details
- PMA number
- P000011
- Supplement
- S004
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIODIVYSIO OC/OTW STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2001-08-31
- Decision date
- 2002-03-01
- Days to decision
- 182 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE BIODIVYSIO OC OTW IN 11 MM, 15 MM, 18 MM, 22 MM AND 28 MM STENT LENGTHS AND 3.0 MM, 3.5 MM AND 4.0 MM DIAMETERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIODIVYSIO OC OTW AND IS INDICATED FOR: "USE IN SUBJECTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DE NOVO NATIVE CORONARY ARTERY LESIONS (LENGTH <= 25 MM) WITH A REFERENCE VESSEL DIAMETER RANGING FROM >= 3.0 MM TO <= 4.0 MM AND INTENDED TO IMPROVE CORONARY LUMINAL DIAMETER. LONG-TERM OUTCOME (BEYOND
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Hi-Torque JET Guide Wire Family (K142415) | Abbott Vascular, Inc. | 2014-12-19 |
| PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY (K123067) | Abbott Vascular, Inc. | 2013-01-29 |
| 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 |