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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.
 
DeviceOMNILINK ELITE VACULAR SYSTEM
Generic NameSTENT, ILIAC
ApplicantAbbott Vascular-Cardiac Therapies
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP110043
Supplement NumberS006
Date Received04/14/2014
Decision Date05/13/2014
Product Code NIO 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ADDITION OF RECEIVING INSPECTION AND TESTING ACTIVITIES OF RAW MATERIALS AND SUPPLY ITEMS AT THE CLONMEL, IRELAND FACILITY AND CONTRACT LABORATORIES.
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