PMA P950018S024
- Device
- Perfluoron
- Applicant
- Alcon Laboratories
- PMA number
- P950018
- Supplement
- S024
- Product code
- LWL
- Decision date
- 2023-08-29
- Classification
- Ophthalmic
- Generic name
- Fluid, intraocular
- Approval order statement
- Change to add an alternate sterilization cycle for items used in the filling operation of the Perfluoron product.
Current openFDA PMA Record#
- Device
- Perfluoron
- Applicant
- Alcon Laboratories
- PMA number
- P950018
- Supplement
- S024
- Product code
- LWL
- Generic name
- Fluid, intraocular
- Decision date
- 2023-08-29
- Decision code
- OK30
- Date received
- 2023-08-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to add an alternate sterilization cycle for items used in the filling operation of the Perfluoron product.