PMA P950008S015
- Device
- Silikon 1000
- Applicant
- Alcon
- PMA number
- P950008
- Supplement
- S015
- Product code
- LWL
- Decision date
- 2021-02-15
- Generic name
- Fluid, intraocular
- Approval order statement
- Implementation of an alternate indicator for demonstrating successful terminal sterilization for Silikon 1000.
Current openFDA PMA Record#
- Device
- Silikon 1000
- Applicant
- Alcon
- PMA number
- P950008
- Supplement
- S015
- Product code
- LWL
- Generic name
- Fluid, intraocular
- Decision date
- 2021-02-15
- Decision code
- OK30
- Date received
- 2021-01-19
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Implementation of an alternate indicator for demonstrating successful terminal sterilization for Silikon 1000.