Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | ACS MULTI-LINK RX AND OTW PIXEL CORONARY STENT SYSTEMS |
Generic Name | STENT, CORONARY |
Applicant | ABBOTT VASCULAR INC. 26531 YNEZ ROAD TEMECULA, CA 92591 |
PMA Number | P970020 |
Supplement Number | S030 |
Date Received | 02/05/2001 |
Decision Date | 06/01/2001 |
Product Code |
MAF |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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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