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.
Changes to the hplc chromatography column and test method used to evaluate the protein aggregate content in the human serum albumin component of the chemistry kits contained in the progel pals and tridyne vs finished devices
| Device | Progel Pleural Air Leak Sealant |
| Generic Name | Sealant, Polymerizing |
| Applicant | NEOMEND, INC. |
| Date Received | 2020-05-01 |
| Decision Date | 2020-12-21 |
| PMA | P010047 |
| Supplement | S062 |
| Product Code | NBE |
| Advisory Committee | Anesthesiology |
| Supplement Type | 135 Review Track For 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 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P010047 | Original Filing | |
| 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 |