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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.
 
DeviceLimFlow System
Generic NameStent graft, infrapopliteal, venous arterialization
ApplicantLimFlow, Inc.
3031 Tisch Way - 110 Plz. W.
San Jose, CA 95128
PMA NumberP220025
Supplement NumberS004
Date Received07/23/2024
Decision Date12/20/2024
Product Code QWN 
Advisory Committee Cardiovascular
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
the use of an additional sterilization chamber for ethylene oxide sterilization at the current contract sterilization facility.
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