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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceACS MULTI-LINK RX/OTW DUET CORONARY STENT SYSTEMS
Generic NameSTENT, CORONARY
ApplicantABBOTT VASCULAR INC.
26531 YNEZ ROAD
TEMECULA, CA 92591
PMA NumberP970020
Supplement NumberS040
Date Received12/26/2001
Decision Date08/06/2002
Product Code MAF 
Docket Number 04M-0024
Notice Date 01/21/2004
Advisory Committee Cardiovascular
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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