Tryton Side Branch Stent

Stent, Coronary

FDA Premarket Approval P150039 S004

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

To add new equipment, leak testers and hot air boxes, for use on the tryton product during the manufacturing and testing process

• Device: Tryton Side Branch Stent
• Classification Name: Stent, Coronary
• Generic Name: Stent, Coronary
• Applicant: TRYTON MEDICAL, INC.
• Date Received: 2019-06-07
• Decision Date: 2019-07-02
• PMA: P150039
• Supplement: S004
• Product Code: MAF
• Advisory Committee: Cardiovascular
• Supplement Type: 30-day Notice
• Supplement Reason: Process Change - Manufacturer/sterilizer/packager/supplier
• Expedited Review: No
• Combination Product: No
• Applicant Address: TRYTON MEDICAL, INC. 1000 Park 40 Plaza Suite 325 durham, NC 27713

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