Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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 ULTRA CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantABBOTT VASCULAR INC.
26531 YNEZ ROAD
TEMECULA, CA 92591
PMA NumberP970020
Supplement NumberS035
Date Received08/06/2001
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 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.
-
-