PMA P950008S017
- Device
- Silikon 1000
- Applicant
- Alcon
- PMA number
- P950008
- Supplement
- S017
- Product code
- LWL
- Decision date
- 2023-02-22
- Classification
- Ophthalmic
- Generic name
- Fluid, intraocular
- Approval order statement
- Add Alcon Laboratories, Inc., the Fort Worth North (FWN) quality control (QC) lab, as a testing location for finished device and device component resistivity testing.
Current openFDA PMA Record#
- Device
- Silikon 1000
- Applicant
- Alcon
- PMA number
- P950008
- Supplement
- S017
- Product code
- LWL
- Generic name
- Fluid, intraocular
- Decision date
- 2023-02-22
- Decision code
- OK30
- Date received
- 2023-02-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add Alcon Laboratories, Inc., the Fort Worth North (FWN) quality control (QC) lab, as a testing location for finished device and device component resistivity testing.