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.
| Device | PROGEL PLEURAL LEAK SEALANT |
| Classification Name | Sealant, Polymerizing |
| Generic Name | Sealant, Polymerizing |
| Applicant | NEOMEND, INC. |
| Date Received | 2012-01-30 |
| Decision Date | 2012-03-23 |
| PMA | P010047 |
| Supplement | S016 |
| Product Code | NBE |
| Advisory Committee | Anesthesiology |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | NEOMEND, INC. 60 Technology Dr. irvine, CA 92618 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P010047 | | Original 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