PMA P130004S008
- Device
- ReSure Sealant
- Applicant
- Ocular Therapeutix, Inc.
- PMA number
- P130004
- Supplement
- S008
- Product code
- PFZ
- Decision date
- 2020-05-05
- Generic name
- Ophthalmic Sealant
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS), Device Exposure Registry Study.
Current openFDA PMA Record#
- Device
- ReSure Sealant
- Applicant
- Ocular Therapeutix, Inc.
- PMA number
- P130004
- Supplement
- S008
- Product code
- PFZ
- Generic name
- Ophthalmic Sealant
- Decision date
- 2020-05-05
- Decision code
- APPR
- Date received
- 2019-12-11
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS), Device Exposure Registry Study.