TRIDYNE Vascular Sealant

FDA Premarket Approval P150016 S022

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

DeviceTRIDYNE Vascular Sealant
Generic NameSealant, Polymerizing
ApplicantNEOMEND, INC.60 Technology Dr.irvine, CA 92618 PMA NumberP150016 Supplement NumberS022 Date Received08/08/2022 Decision Date09/07/2022 Product Code NBE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-08-08
Decision Date2022-09-07
PMAP150016
SupplementS022
Product CodeNBE 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressNEOMEND, INC.
60 Technology Dr.
irvine, CA 92618 PMA NumberP150016 Supplement NumberS022 Date Received08/08/2022 Decision Date09/07/2022 Product Code NBE  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
a Relocation Of The Glass Cartridge Syringe Manufacturing Supplier Site

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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