ReSure Sealant
FDA premarket approval P130004/S009 · decided 2020-07-16
Approval details
- PMA number
- P130004
- Supplement
- S009
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ReSure Sealant
- Generic name
- Ophthalmic Sealant
- Applicant
- Ocular Therapeutix, Inc.
- Date received
- 2020-06-18
- Decision date
- 2020-07-16
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- PFZ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Bedford, MA
- Statement
- Change to the reference dose and the delivered dose range for the routine gamma radiation process.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| OCULAR FORCE GAUGE (K132917) | Ocular Therapeutix, Inc. | 2013-12-20 |