Approval to modify the storage conditions of tridyne vascular sealant (tridyne vs) from refrigerated conditions 2-8°c (36-46°f) to include a controlled ambient temperature storage excursion of 8-25°c (46-77°f) for a period of up to 35 days within the approved shelf life of 24 months.
| Device | TRIDYNE VASCULAR SEALANT |
| Classification Name | Sealant, Polymerizing |
| Generic Name | Sealant, Polymerizing |
| Applicant | NEOMEND, INC. |
| Date Received | 2017-04-10 |
| Decision Date | 2017-07-06 |
| PMA | P150016 |
| Supplement | S005 |
| Product Code | NBE |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| 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