PMA P130004S002
- Device
- RESURE SEALANT
- Applicant
- Ocular Therapeutix, Inc.
- PMA number
- P130004
- Supplement
- S002
- Product code
- PFZ
- Decision date
- 2016-07-21
- Classification
- Ophthalmic Sealant
- Generic name
- Ophthalmic Sealant
- Approval order statement
- Approval for the ReSure® Sealant Device Exposure Registry post-approval study protocol.
Current openFDA PMA Record#
- Device
- RESURE SEALANT
- Applicant
- Ocular Therapeutix, Inc.
- PMA number
- P130004
- Supplement
- S002
- Product code
- PFZ
- Generic name
- Ophthalmic Sealant
- Decision date
- 2016-07-21
- Decision code
- APPR
- Date received
- 2014-02-07
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol - OSB
- Approval order statement
- Approval for the ReSure® Sealant Device Exposure Registry post-approval study protocol.