BIODIVYSIO AS OTW
FDA premarket approval P000011/S002 · decided 2001-07-03
Approval details
- PMA number
- P000011
- Supplement
- S002
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- BIODIVYSIO AS OTW
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2001-01-18
- Decision date
- 2001-07-03
- Days to decision
- 166 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE 11 MM AND 15 MM BIODIVYSIO(TM) AS OTW. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME BIODIVYSIO(TM) AS 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 LUMEN DIAMETER. LONG TERM OUTCOME (BEYOND 6 MONTHS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT."
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 |
|---|---|---|
| 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 |