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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 NumberS003
Date Received09/29/2017
Decision Date03/28/2018
Product Code MAF 
Advisory Committee Cardiovascular
Clinical TrialsNCT01258972
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for updates to the labeling to include complete follow-up for the Pivotal RCT and EA Confirmatory Studies.
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