PMA P950008S023
- Device
- Silikon 1000
- Applicant
- Alcon
- PMA number
- P950008
- Supplement
- S023
- Product code
- LWL
- Decision date
- 2024-06-03
- Classification
- Ophthalmic
- Generic name
- Fluid, intraocular
- Approval order statement
- Add Alcon Laboratories, Fort Worth North Manufacturing laboratory as an approved laboratory to perform testing of Ethanol using the same method, in addition to the approved contract laboratories.
Current openFDA PMA Record#
- Device
- Silikon 1000
- Applicant
- Alcon
- PMA number
- P950008
- Supplement
- S023
- Product code
- LWL
- Generic name
- Fluid, intraocular
- Decision date
- 2024-06-03
- Decision code
- OK30
- Date received
- 2024-05-06
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add Alcon Laboratories, Fort Worth North Manufacturing laboratory as an approved laboratory to perform testing of Ethanol using the same method, in addition to the approved contract laboratories.