RESURE SEALANT
FDA premarket approval P130004 · decided 2014-01-08
Approval details
- PMA number
- P130004
- Trade name
- RESURE SEALANT
- Generic name
- Ophthalmic Sealant
- Applicant
- Ocular Therapeutix, Inc.
- Date received
- 2013-02-01
- Decision date
- 2014-01-08
- Days to decision
- 341 days
- Decision code
- APWD
- Product code
- PFZ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- 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.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| OCULAR FORCE GAUGE (K132917) | Ocular Therapeutix, Inc. | 2013-12-20 |