PMA P130004S010
- Device
- Resure Sealant
- Applicant
- Ocular Therapeutix, Inc.
- PMA number
- P130004
- Supplement
- S010
- Product code
- PFZ
- Decision date
- 2020-12-17
- Generic name
- Ophthalmic Sealant
- Approval order statement
- to modify the test method for the ReSure Sealant Hydrogel and Dropper Bottle Performance
Current openFDA PMA Record#
- Device
- Resure Sealant
- Applicant
- Ocular Therapeutix, Inc.
- PMA number
- P130004
- Supplement
- S010
- Product code
- PFZ
- Generic name
- Ophthalmic Sealant
- Decision date
- 2020-12-17
- Decision code
- OK30
- Date received
- 2020-12-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to modify the test method for the ReSure Sealant Hydrogel and Dropper Bottle Performance