PMA P130004S009
- Device
- ReSure Sealant
- Applicant
- Ocular Therapeutix, Inc.
- PMA number
- P130004
- Supplement
- S009
- Product code
- PFZ
- Decision date
- 2020-07-16
- Generic name
- Ophthalmic Sealant
- Approval order statement
- Change to the reference dose and the delivered dose range for the routine gamma radiation process.
Current openFDA PMA Record#
- Device
- ReSure Sealant
- Applicant
- Ocular Therapeutix, Inc.
- PMA number
- P130004
- Supplement
- S009
- Product code
- PFZ
- Generic name
- Ophthalmic Sealant
- Decision date
- 2020-07-16
- Decision code
- OK30
- Date received
- 2020-06-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the reference dose and the delivered dose range for the routine gamma radiation process.