Approval for updates to the labeling to include the findings of the post-approval study (pas) designated as the retrospective analysis study for endophthalmitis
| Device | ReSure Sealant |
| Generic Name | Ophthalmic Sealant |
| Applicant | OCULAR THERAPEUTIX, INC. |
| Date Received | 2021-06-10 |
| Decision Date | 2021-11-02 |
| PMA | P130004 |
| Supplement | S011 |
| Product Code | PFZ |
| Advisory Committee | Ophthalmic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Pas |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | OCULAR THERAPEUTIX, INC. 36 Crosby Dr Suite 101 bedford, MA 01730 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P130004 | | Original Filing |
| S011 |
2021-06-10 |
Normal 180 Day Track No User Fee |
| S010 |
2020-12-02 |
30-day Notice |
| S009 |
2020-06-18 |
30-day Notice |
| S008 |
2019-12-11 |
Normal 180 Day Track No User Fee |
| S007 |
2019-06-27 |
30-day Notice |
| S006 | | |
| S005 |
2014-09-09 |
30-day Notice |
| S004 |
2014-02-25 |
30-day Notice |
| S003 | | |
| S002 |
2014-02-07 |
Normal 180 Day Track No User Fee |
| S001 |
2014-02-07 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices