MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEM
FDA premarket approval P970020/S021 · decided 2000-09-08
Approval details
- PMA number
- P970020
- Supplement
- S021
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEM
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2000-03-17
- Decision date
- 2000-09-08
- Days to decision
- 175 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE ACS MULTI-LINK RX AND OTW ULTRA(TM) CORONARY STENT SYSTEMS. THE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMEN DIAMETER IN THE FOLLOWING: 1) PATIENTS WITH SYNTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <= 25 MM) WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM TO 5.0 MM; AND 2) TREATMENT OF ABRUPT OR THREATENED ABRUPT CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<= 35 MM IN LENGTH) WITH REFERENCE DIAME
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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 |