This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the resure® sealant. This device is indicated for intraoperative management of clear corneal incisions (up to 3. 5mm) with a demonstrated wound leak for which a temporary dry surface can be achieved, in order to prevent postoperative fluid egress from such incisions following cataract surgery with intraocular lens (iol) placement in adults.
| Device | RESURE SEALANT |
| Classification Name | Ophthalmic Sealant |
| Generic Name | Ophthalmic Sealant |
| Applicant | OCULAR THERAPEUTICS, INC. |
| Date Received | 2013-02-01 |
| Decision Date | 2014-01-08 |
| Notice Date | 2014-01-15 |
| PMA | P130004 |
| Supplement | S |
| Product Code | PFZ |
| Docket Number | 14M-0069 |
| Advisory Committee | Ophthalmic |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | OCULAR THERAPEUTICS, INC. 36 Crosby Dr Suite 101 bedford, MA 01730 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00867968000011 | P130004 | 000 |
| 00867968000004 | P130004 | 000 |