Progel Pleural Air Leak Sealant (Progel™ PALS)

FDA Premarket Approval P010047 S064

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

The addition of an equivalent piece of testing equipment utilized in a lot release test

DeviceProgel Pleural Air Leak Sealant (Progel™ PALS)
Generic NameSealant, Polymerizing
ApplicantNEOMEND, INC.
Date Received2021-01-14
Decision Date2021-02-11
PMAP010047
SupplementS064
Product CodeNBE 
Advisory CommitteeAnesthesiology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address NEOMEND, INC. 60 Technology Dr. irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P010047Original Filing
S064 2021-01-14 30-day Notice
S063
S062 2020-05-01 135 Review Track For 30-day Notice
S061 2019-01-23 30-day Notice
S060 2018-08-17 30-day Notice
S059 2018-06-27 30-day Notice
S058 2018-05-14 30-day Notice
S057 2018-04-25 30-day Notice
S056 2018-04-06 30-day Notice
S055 2018-01-09 30-day Notice
S054 2018-01-04 135 Review Track For 30-day Notice
S053 2018-01-04 30-day Notice
S052
S051 2017-11-29 Normal 180 Day Track No User Fee
S050 2017-10-23 30-day Notice
S049 2017-09-07 30-day Notice
S048 2017-09-07 30-day Notice
S047 2017-09-07 30-day Notice
S046 2017-08-28 135 Review Track For 30-day Notice
S045
S044 2016-09-23 30-day Notice
S043 2016-07-18 30-day Notice
S042 2015-12-28 30-day Notice
S041 2015-11-20 30-day Notice
S040 2015-11-12 30-day Notice
S039 2015-05-28 30-day Notice
S038
S037 2015-03-02 Normal 180 Day Track No User Fee
S036 2014-07-11 Panel Track
S035 2014-06-02 30-day Notice
S034 2014-03-07 Real-time Process
S033 2013-12-31 30-day Notice
S032 2013-12-30 Normal 180 Day Track
S031 2013-07-03 30-day Notice
S030 2013-06-28 Real-time Process
S029 2013-04-11 30-day Notice
S028 2013-03-07 Normal 180 Day Track No User Fee
S027 2013-03-07 135 Review Track For 30-day Notice
S026 2012-11-20 Normal 180 Day Track
S025
S024 2012-10-11 Normal 180 Day Track No User Fee
S023 2012-09-24 30-day Notice
S022 2012-08-20 135 Review Track For 30-day Notice
S021 2012-07-12 Real-time Process
S020 2012-05-01 30-day Notice
S019 2012-04-06 Real-time Process
S018 2012-03-23 30-day Notice
S017 2012-02-01 30-day Notice
S016 2012-01-30 Real-time Process
S015 2012-01-19 Normal 180 Day Track No User Fee
S014 2011-10-07 30-day Notice
S013 2011-09-16 30-day Notice
S012
S011 2011-05-19 Normal 180 Day Track
S010 2011-01-28 Normal 180 Day Track
S009 2011-01-28 Normal 180 Day Track No User Fee
S008 2011-01-07 30-day Notice
S007
S006 2010-09-08 30-day Notice
S005 2010-08-11 135 Review Track For 30-day Notice
S004 2010-06-29 30-day Notice
S003 2010-04-20 30-day Notice
S002 2010-03-16 30-day Notice
S001 2010-02-23 Normal 180 Day Track No User Fee

NIH GUDID Devices

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