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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.
 
DeviceABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM
Generic NameSTENT, ILIAC
ApplicantAbbott Vascular, Inc.
3200 Lakeside Dr.
Santa Clara, CA 92054
PMA NumberP110028
Supplement NumberS007
Date Received01/14/2013
Decision Date02/12/2013
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  
ALIGN CLEAN ROOM ACTION LIMITS WITH A NEW STANDARD.
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