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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 NumberS031
Date Received12/18/2023
Decision Date01/17/2024
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  
new ethylene oxide sterilization processing parameter specifications in Chamber 8 at Sterigenics Los Angeles
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