ACS MULTI-LINK RX/OTW DUET CORONARY STENT SYSTEMS
FDA premarket approval P970020/S040 · decided 2002-08-06
Approval details
- PMA number
- P970020
- Supplement
- S040
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- ACS MULTI-LINK RX/OTW DUET CORONARY STENT SYSTEMS
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2001-12-26
- Decision date
- 2002-08-06
- Days to decision
- 223 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. THE ACS MULTI-LINK DEVICES ARE INDICATED FOR THE FOLLOWING (SEE INDIVIDUALIZATION OF TREATMENT): 1) IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS LENGTH <= 25 MM WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM TO 4.0 MM. 2) IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BY
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510(k) clearances by this applicant
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|---|---|---|
| Hi-Torque JET Guide Wire Family (K142415) | Abbott Vascular, Inc. | 2014-12-19 |
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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 |