PMA P950008S019
- Device
- Silikon 1000
- Applicant
- Alcon
- PMA number
- P950008
- Supplement
- S019
- Product code
- LWL
- Decision date
- 2023-09-15
- Classification
- Ophthalmic
- Generic name
- Fluid, intraocular
- Approval order statement
- Approval for an additional alternate sterilizer for the in-house dry heat sterilization of the Silikon 1000 product.
Current openFDA PMA Record#
- Device
- Silikon 1000
- Applicant
- Alcon
- PMA number
- P950008
- Supplement
- S019
- Product code
- LWL
- Generic name
- Fluid, intraocular
- Decision date
- 2023-09-15
- Decision code
- APPR
- Date received
- 2023-05-22
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval for an additional alternate sterilizer for the in-house dry heat sterilization of the Silikon 1000 product.