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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 NumberS018
Date Received03/21/2017
Decision Date04/07/2017
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  
Change to the frequency of routine bacterial endotoxin testing.
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