Approval for the progel pleural air leak sealant (pals). The single use progel pleural air leak sealant device is indicated for application to visceral pleura after standard visceral pleural closure with, for example, sutures or staples, of visible air leaks incurred during resection of lung parenchyma.
| Device | PROGEL PLEURAL AIR LEAK SEALANT |
| Classification Name | Sealant, Polymerizing |
| Generic Name | Sealant, Polymerizing |
| Applicant | NEOMEND, INC. |
| Date Received | 2014-07-11 |
| Decision Date | 2015-02-13 |
| Notice Date | 2015-03-19 |
| PMA | P010047 |
| Supplement | S036 |
| Product Code | NBE |
| Docket Number | 15M-0502 |
| Advisory Committee | Anesthesiology |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NEOMEND, INC. 60 Technology Dr. irvine, CA 92618 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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