Tryton Side Branch Stent

FDA Premarket Approval P150039 S005

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.

Pre-market Approval Supplement Details

Approval for early termination of enrollment for the post-approval study (pas) referenced above. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p150039.

DeviceTryton Side Branch Stent
Generic NameStent, Coronary
ApplicantPoseidon Medical Inc.
Date Received2020-09-04
Decision Date2020-10-04
PMAP150039
SupplementS005
Product CodeMAF 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement ReasonPostapproval Study Protocol - Ode/oir
Expedited ReviewNo
Combination Product No
Applicant Address Poseidon Medical Inc. 1125 Nw 132nd Avenue pembroke Pines, FL 33028

Supplemental Filings

Supplement NumberDateSupplement Type
P150039Original Filing
S005 2020-09-04 Normal 180 Day Track No User Fee
S004 2019-06-07 30-day Notice
S003 2017-09-29 Normal 180 Day Track No User Fee
S002 2017-07-11 30-day Notice
S001 2017-03-13 Normal 180 Day Track No User Fee

NIH GUDID Devices

Device IDPMASupp
00894588002187 P150039 000
00894588002170 P150039 000
00894588002163 P150039 000
00894588002156 P150039 000
00894588002149 P150039 000
00894588002132 P150039 000
00894588002125 P150039 000

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