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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 TETRA/OTW TETRA CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantABBOTT VASCULAR INC.
26531 YNEZ ROAD
TEMECULA, CA 92591
PMA NumberP970020
Supplement NumberS039
Date Received11/27/2001
Decision Date05/23/2002
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR INCLUSION OF SIX-MONTH TRIAL DATA IN THE INSTRUCTIONS FOR USE BOOKLET FOR THE MULTI-LINK RX AND OTW TETRA CORONARY STENT SYSTEMS. THE MULTI-LINK RX AND OTW TETRA CORONARY STENT SYSTEMS ARE INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN THE FOLLOWING: 1) PATIENTS WITH SYMPTOMATIC ISCHEMIC DISEASE DUE TO DISCRETE DE NOVO OR RESTENOTIC NATIVE CORONARY ARTERY LESIONS (LENGTH <= 25 MM) WITH REFERENCE VESSEL DIAMETERS OF 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 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 VESSEL DIAMETERS RANGING FROM 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 DIAMETER STENTS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE. THE 33 MM AND 38 MM LENGTH STENTS ARE SOLELY INDICATED FOR USE IN PATIENTS WITH ABRUPT OR THREATENED ABRUPT CLOSURE AND PATIENTS WITH LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS.
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