PROGEL PLEURAL LEAK SEALANT

Sealant, Polymerizing

FDA Premarket Approval P010047 S016

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 for an extension of shelf life of the progel extended applicator spray tips form 12 to 24 months. The device, as modified, will be marketed under the trade name progel extended applicator spray tips and is indicated to deliver progel to visceral pleura during an open thoracotomy after standard visceral pleural closure (i. E. With sutures or staples) of visible air leaks (>= 2 mm) incurred during open resection of lung parenchyma in adult humans by bending the malleable tip to direct progel from the delivery tip in a stream or spray cone pattern that is perpendicular to thetarget surface.

DevicePROGEL PLEURAL LEAK SEALANT
Classification NameSealant, Polymerizing
Generic NameSealant, Polymerizing
ApplicantNEOMEND, INC.
Date Received2012-01-30
Decision Date2012-03-23
PMAP010047
SupplementS016
Product CodeNBE
Advisory CommitteeAnesthesiology
Supplement TypeReal-time Process
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product Yes
Applicant Address NEOMEND, INC. 60 Technology Dr. irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P010047Original Filing
S067 2022-08-08 30-day Notice
S066 2021-08-16 30-day Notice
S065
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

Device IDPMASupp
10801741010023 P010047 000
20801741010037 P010047 008
10801741010016 P010047 010
10801741010009 P010047 010

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.