ACS MULTI-LINK RX AND OTW PIXEL CORONARY STENT SYSTEMS
FDA premarket approval P970020/S030 · decided 2001-06-01
Approval details
- PMA number
- P970020
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ACS MULTI-LINK RX AND OTW PIXEL CORONARY STENT SYSTEMS
- Generic name
- STENT, CORONARY
- Applicant
- Abbott Vascular, Inc.
- Date received
- 2001-02-05
- Decision date
- 2001-06-01
- Days to decision
- 116 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Temecula, CA
- Statement
- APPROVAL FOR THE ACS MULTI-LINK CORONARY STENT SYSTEMS. THE DEVICES ARE INDICATED FOR IMPROVING CORONARY LUMEN DIAMETER IN THE FOLLOWING: PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE WITH FAILED INTERVENTIONAL THERAPY OF DE NOVO AND RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <25 MM) WITH REFERENCE DIAMETERS FROM 2.0 TO 2.5 MM. LONG TERM OUTCOME FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT.
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| FOXCROSS PTA CATHETER (K081417) | Abbott Vascular, Inc. | 2008-06-04 |