PMA P950008S016
- Device
- Silikon 1000
- Applicant
- Alcon
- PMA number
- P950008
- Supplement
- S016
- Product code
- LWL
- Decision date
- 2023-08-02
- Classification
- Ophthalmic
- Generic name
- Fluid, intraocular
- Approval order statement
- Approval to implement the single re-use of the polishing filter on two bulk batches of Silikon 1000 (silicone oil) during the compounding process.
Current openFDA PMA Record#
- Device
- Silikon 1000
- Applicant
- Alcon
- PMA number
- P950008
- Supplement
- S016
- Product code
- LWL
- Generic name
- Fluid, intraocular
- Decision date
- 2023-08-02
- Decision code
- APPR
- Date received
- 2023-02-01
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Approval to implement the single re-use of the polishing filter on two bulk batches of Silikon 1000 (silicone oil) during the compounding process.