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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 NumberS005
Date Received09/04/2020
Decision Date10/04/2020
Product Code MAF 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for early termination of enrollment for the post-approval study (PAS) protocol.
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