ACS MULTI-LINK RX/OTW DUET(TM) CORONARY STENT SYSTEM - REVIVE REGISTRY
FDA premarket approval P970020/S031 · decided 2001-06-05
Approval details
- PMA number
- P970020
- Supplement
- S031
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACS MULTI-LINK RX/OTW DUET(TM) CORONARY STENT SYSTEM - REVIVE REGISTRY
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2001-04-11
- Decision date
- 2001-06-05
- Days to decision
- 55 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE ADDITION OF A NEW INDICATION FOR THE ACS MULTI-LINK RX AND OTW D, TRISTAR, ULTR TETRA CORONARY STENT SYSTEMS AND ACS MULTI-LINK. STENT AND THE FOUR DELIVERY SYSTEMS. THE NEW ADDITIONAL INDICATION FOR THESE DEVICES IS FOR USE IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS (LENGTH = 25 MM) WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM TO 4.0 MM.
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 |