PMA P130004S011
- Device
- ReSure Sealant
- Applicant
- Ocular Therapeutix, Inc.
- PMA number
- P130004
- Supplement
- S011
- Product code
- PFZ
- Decision date
- 2021-11-02
- Generic name
- Ophthalmic Sealant
- Approval order 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.
Current openFDA PMA Record#
- Device
- ReSure Sealant
- Applicant
- Ocular Therapeutix, Inc.
- PMA number
- P130004
- Supplement
- S011
- Product code
- PFZ
- Generic name
- Ophthalmic Sealant
- Decision date
- 2021-11-02
- Decision code
- APPR
- Date received
- 2021-06-10
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order 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.