Approval for the progel applicator extended spray tips as an accessory for the progel pleural air leak sealant. The device, as modified, will be marketed under the trade name progel applicator extended spray tips and the indications for use is 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 the target surface.
| Device | NEOMEND PROGEL PLEURAL AIR LEAK SEALANT |
| Classification Name | Sealant, Polymerizing |
| Generic Name | Sealant, Polymerizing |
| Applicant | NEOMEND, INC. |
| Date Received | 2011-01-28 |
| Decision Date | 2011-12-21 |
| PMA | P010047 |
| Supplement | S010 |
| Product Code | NBE |
| Advisory Committee | Anesthesiology |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | NEOMEND, INC. 60 Technology Dr. irvine, CA 92618 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
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