TRIDYNE VASCULAR SEALANT

Sealant, Polymerizing

FDA Premarket Approval P150016 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 to modify the storage conditions of tridyne vascular sealant (tridyne vs) from refrigerated conditions 2-8°c (36-46°f) to include a controlled ambient temperature storage excursion of 8-25°c (46-77°f) for a period of up to 35 days within the approved shelf life of 24 months.

DeviceTRIDYNE VASCULAR SEALANT
Classification NameSealant, Polymerizing
Generic NameSealant, Polymerizing
ApplicantNEOMEND, INC.
Date Received2017-04-10
Decision Date2017-07-06
PMAP150016
SupplementS005
Product CodeNBE
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
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
S022 2022-08-08 30-day Notice
S021 2021-08-16 30-day Notice
S020 2021-01-14 30-day Notice
S019
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
10801741099363 P150016 000
20801741099377 P150016 000

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