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Device | ACS MULTI-LINK RX/OTW DUET CORONARY STENT SYSTEMS |
Generic Name | STENT, CORONARY |
Applicant | ABBOTT VASCULAR INC. 26531 YNEZ ROAD TEMECULA, CA 92591 |
PMA Number | P970020 |
Supplement Number | S040 |
Date Received | 12/26/2001 |
Decision Date | 08/06/2002 |
Product Code |
MAF |
Docket Number | 04M-0024 |
Notice Date | 01/21/2004 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order 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 BYPASS GRAFTS LENGTH <= 35 MM WITH A REFERENCE VESSEL DIAMETER OF 3.0 MM TO 4.0 MM. 3) RESTORING CORONARY FLOW IN PATIENTS EXPERIENCING ACUTE MYOCARDIAL INFARCTION, AS CONFIRMED BY ST SEGMENT ELEVATION OR ANGIOGRAPHIC FINDINGS, WHO PRESENT WITHIN 12 HOURS OF SYMPTOM ONSET WITH NATIVE CORONARY ARTERY LESIONS OF LENGTH <= 35 MM WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM TO 4.0 MM. 4) TREATMENT OF ABRUPT OR THREATENED CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS LENGTH <= 35 MM WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM TO 4.0 MM. LONG-TERM OUTCOME (BEYOND 6 MONTHS) FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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