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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceACS MULTI-LINK RX/OTW ULTRA CORONARY STENT SYSTEM
Classification Namestent, coronary
Generic Namestent, coronary
Applicant
ABBOTT VASCULAR INC.
26531 ynez road
temecula, CA 92591
PMA NumberP970020
Supplement NumberS035
Date Received08/06/2001
Decision Date01/14/2002
Product Code
MAF[ Registered Establishments with MAF ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE ADDITION OF AN INDICATION TO USE THE 4.5 MM AND 5.0 MM ULTRA OTW AND RX FOR THE TREATMENT OF SAPHENOUS VEIN GRAFT (SVG) LESIONS. THE MULTI-LINK RX ULTRA AND MULTI-LINK OTW ULTRA 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 REFERENCE VESSEL EIAMETERS RANGING FROM 3.5 MM TO 5.0 MM; 2) PATIENTS WITH SYMPTOMATIC ISCHEMIC HEART DISEASE DUE TO LESIONS IN SAPHENOUS VEIN BYPASS GRAFTS (LENGTH <=35) WITH REFERENCE VESSEL DIAMETERS RANGING FROM 3.5 MM TO 5.0 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 3.5 MM TO 5.0 MM. LONG TERM OUTCOME FOR THIS PERMANENT IMPLANT IS UNKNOWN AT PRESENT. NOTE: THE 38 MM LENTGH 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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