Tridyne Vascular Sealant

FDA Premarket Approval P150016 S018

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

Changes to the hplc chromatography column and test method used to evaluate the protein aggregate content in the human serum albumin component of the chemistry kits contained in the progel pals and tridyne vs finished devices

DeviceTridyne Vascular Sealant
Generic NameSealant, Polymerizing
ApplicantNEOMEND, INC.
Date Received2020-05-01
Decision Date2020-12-21
PMAP150016
SupplementS018
Product CodeNBE 
Advisory CommitteeCardiovascular
Supplement Type135 Review Track For 30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address NEOMEND, INC. 60 Technology Dr. irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P150016Original Filing
S018 2020-05-01 135 Review Track For 30-day Notice
S017 2019-01-23 30-day Notice
S016 2018-08-17 30-day Notice
S015 2018-06-27 30-day Notice
S014 2018-05-14 30-day Notice
S013 2018-04-06 30-day Notice
S012 2018-01-22 Real-time Process
S011 2018-01-09 30-day Notice
S010 2017-11-29 Normal 180 Day Track No User Fee
S009 2017-11-28 135 Review Track For 30-day Notice
S008 2017-11-28 30-day Notice
S007 2017-11-28 30-day Notice
S006 2017-10-23 30-day Notice
S005 2017-04-10 Real-time Process
S004
S003 2016-10-25 30-day Notice
S002 2016-10-19 30-day Notice
S001 2016-06-29 30-day Notice

NIH GUDID Devices

Device IDPMASupp
10801741099387 P150016 000
10801741099387 P150016 000
20801741099377 P150016 000
10801741099387 P150016 000
20801741099377 P150016 000
10801741099387 P150016 000
20801741099377 P150016 000
10801741099387 P150016 000
20801741099377 P150016 000
10801741099387 P150016 000
20801741099377 P150016 000
10801741099387 P150016 000
20801741099377 P150016 000
10801741099387 P150016 000
20801741099377 P150016 000
20801741099377 P150016 000
10801741099387 P150016 000
20801741099377 P150016 000
10801741099363 P150016 000
10801741099387 P150016 000
10801741099363 P150016 000
20801741099377 P150016 000
20801741099377 P150016 000
10801741099387 P150016 000
20801741099377 P150016 000
10801741099387 P150016 000
20801741099377 P150016 000
10801741099387 P150016 000
20801741099377 P150016 000
10801741099387 P150016 000
20801741099377 P150016 000
10801741099387 P150016 000
10801741099387 P150016 000

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