PMA P950008S018
- Device
- Silikon 1000
- Applicant
- Alcon
- PMA number
- P950008
- Supplement
- S018
- Product code
- LWL
- Decision date
- 2023-04-20
- Classification
- Ophthalmic
- Generic name
- Fluid, intraocular
- Approval order statement
- Change to the endotoxin test method on finished Silikon 1000 product and the respective releasing specifications.
Current openFDA PMA Record#
- Device
- Silikon 1000
- Applicant
- Alcon
- PMA number
- P950008
- Supplement
- S018
- Product code
- LWL
- Generic name
- Fluid, intraocular
- Decision date
- 2023-04-20
- Decision code
- OK30
- Date received
- 2023-03-22
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the endotoxin test method on finished Silikon 1000 product and the respective releasing specifications.