PMA P130004S007
- Device
- ReSure Sealant
- Applicant
- Ocular Therapeutix, Inc.
- PMA number
- P130004
- Supplement
- S007
- Product code
- PFZ
- Decision date
- 2019-07-25
- Classification
- Ophthalmic Sealant
- Generic name
- Ophthalmic Sealant
- Approval order statement
- Modification to the radiation dose range for sterilization of the ReSure® Sealant.
Current openFDA PMA Record#
- Device
- ReSure Sealant
- Applicant
- Ocular Therapeutix, Inc.
- PMA number
- P130004
- Supplement
- S007
- Product code
- PFZ
- Generic name
- Ophthalmic Sealant
- Decision date
- 2019-07-25
- Decision code
- OK30
- Date received
- 2019-06-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modification to the radiation dose range for sterilization of the ReSure® Sealant.