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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.
 
DeviceSupera Peripheral Stent System
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantAbbott Vascular (Idef Technologies Inc)
3200 Lakeside Dr.
Santa Clara, CA 95054
PMA NumberP120020
Supplement NumberS021
Date Received01/24/2019
Decision Date02/20/2019
Product Code NIP 
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  
Add a third sterilization chamber at the contract sterilizer.
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