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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.
 
DeviceMULTI-LINK RX PENTA CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantABBOTT VASCULAR INC.
26531 YNEZ ROAD
TEMECULA, CA 92591
PMA NumberP970020
Supplement NumberS036
Date Received08/07/2001
Decision Date01/14/2002
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF AN INDICATION TO USE THE 3.0 MM TO 4.0 MM PENTA(TM) OTW AND TX FOR THE TREATMENT OF SVG LESIONS. THE MULTI-LINK RX PENTA AND MULTI-LINK OTW PENTA CORONARY STENT SYSTEM WILL INCLUDE THE FOLLOWING INDICATION: 1) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <=25 MM) WITH REFERENC EVESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM; 2) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS (LENGTH <=35 MM) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.0 MM TO 4.0 MM; AND 3) TREATMENT OF ABRUPT OR THREATENED ABRUPT CLOSURE IN PATIENTS WITH FAILED INTERVENTIONAL THERAPY IN LESIONS (<=35 MM IN LENGTH) WITH REFERENCE DIAMETERS IN THE RANGE OF 2.5 MM TO 4.0 MM. LONG TERM OUTCOME FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT. NOTE: THE 2.5 MM AND 2.75 MM STENTS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE. THE 33 MM AND 38 MM LENGTH STENTS ARE INDICATED SOLELY FOR USE IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE AND PATIENTW WITH LESIONS IN SAPHENOUS BEIN BYPASS GRAFTS.
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