Change to the radiation dose used for the sterile nalgene plastic containers used to store and deliver the polyethylene glycol disuccinimidyl succinate (peg(ss)2) raw material to neomend.
| Device | Progel Pleural Air Leak Sealant |
| Classification Name | Sealant, Polymerizing |
| Generic Name | Sealant, Polymerizing |
| Applicant | NEOMEND, INC. |
| Date Received | 2018-06-27 |
| Decision Date | 2018-07-26 |
| PMA | P010047 |
| Supplement | S059 |
| 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 |
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