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.

• Device: Tryton Side Branch Stent
• Generic Name: Stent, Coronary
• Applicant: Poseidon Medical Inc.
• Date Received: 2020-09-04
• Decision Date: 2020-10-04
• PMA: P150039
• Supplement: S005
• Product Code: MAF
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol - Ode/oir
• Expedited Review: No
• Combination Product: No
• Applicant Address: Poseidon Medical Inc. 1125 Nw 132nd Avenue pembroke Pines, FL 33028

Supplemental Filings

Supplement Number	Date	Supplement Type
P150039		Original 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 ID	PMA	Supp
00894588002187	P150039	000
00894588002170	P150039	000
00894588002163	P150039	000
00894588002156	P150039	000
00894588002149	P150039	000
00894588002132	P150039	000
00894588002125	P150039	000