ReSure Sealant
FDA premarket approval P130004/S011 · decided 2021-11-02
Approval details
- PMA number
- P130004
- Supplement
- S011
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- ReSure Sealant
- Generic name
- Ophthalmic Sealant
- Applicant
- Ocular Therapeutix, Inc.
- Date received
- 2021-06-10
- Decision date
- 2021-11-02
- Days to decision
- 145 days
- Decision code
- APPR
- Product code
- PFZ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- Approval for updates to the labeling to include the findings of the Post-Approval Study (PAS) designated as the Retrospective Analysis Study for Endophthalmitis.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| OCULAR FORCE GAUGE (K132917) | Ocular Therapeutix, Inc. | 2013-12-20 |