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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 NumberS004
Date Received06/07/2019
Decision Date07/02/2019
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  
Add new equipment, leak testers and hot air boxes, for use on the Tryton product during the manufacturing and testing process.
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