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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.
 
DeviceTryton Side Branch Stent
Generic NameSTENT, CORONARY
ApplicantPoseidon Medical, Inc.
1125 NW 132nd Ave.
Pembroke Pines, FL 33028
PMA NumberP150039
Supplement NumberS002
Date Received07/11/2017
Decision Date08/10/2017
Product Code MAF 
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  
Replace the pouch sealer equipment and to modify the sealer process parameters.
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