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.
| Device | PROGEL Pleural Air Leak Sealant |
| Generic Name | Sealant, Polymerizing |
| Applicant | NEOMEND, INC.60 Technology Dr.irvine, CA 92618 PMA NumberP010047 Supplement NumberS067 Date Received08/08/2022 Decision Date09/06/2022 Product Code NBE Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-08-08 |
| Decision Date | 2022-09-06 |
| PMA | P010047 |
| Supplement | S067 |
| Product Code | NBE |
| Advisory Committee | Anesthesiology |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | NEOMEND, INC. 60 Technology Dr. irvine, CA 92618 PMA NumberP010047 Supplement NumberS067 Date Received08/08/2022 Decision Date09/06/2022 Product Code NBE Advisory Committee Anesthesiology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement a Relocation Of The Glass Cartridge Syringe Manufacturing Site |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 10801741010023 | P010047 | 000 |
| 20801741010037 | P010047 | 008 |
| 10801741010016 | P010047 | 010 |
| 10801741010009 | P010047 | 010 |