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 | Tridyne Vascular Sealant |
| Generic Name | Sealant, Polymerizing |
| Applicant | NEOMEND, INC. |
| Date Received | 2020-05-01 |
| Decision Date | 2020-12-21 |
| PMA | P150016 |
| Supplement | S018 |
| Product Code | NBE |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | NEOMEND, INC. 60 Technology Dr. irvine, CA 92618 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150016 | | Original Filing |
| S022 |
2022-08-08 |
30-day Notice |
| S021 |
2021-08-16 |
30-day Notice |
| S020 |
2021-01-14 |
30-day Notice |
| S019 | | |
| S018 |
2020-05-01 |
135 Review Track For 30-day Notice |
| S017 |
2019-01-23 |
30-day Notice |
| S016 |
2018-08-17 |
30-day Notice |
| S015 |
2018-06-27 |
30-day Notice |
| S014 |
2018-05-14 |
30-day Notice |
| S013 |
2018-04-06 |
30-day Notice |
| S012 |
2018-01-22 |
Real-time Process |
| S011 |
2018-01-09 |
30-day Notice |
| S010 |
2017-11-29 |
Normal 180 Day Track No User Fee |
| S009 |
2017-11-28 |
135 Review Track For 30-day Notice |
| S008 |
2017-11-28 |
30-day Notice |
| S007 |
2017-11-28 |
30-day Notice |
| S006 |
2017-10-23 |
30-day Notice |
| S005 |
2017-04-10 |
Real-time Process |
| S004 | | |
| S003 |
2016-10-25 |
30-day Notice |
| S002 |
2016-10-19 |
30-day Notice |
| S001 |
2016-06-29 |
30-day Notice |
NIH GUDID Devices