PMA P950008S013
- Device
- SILIKON 1000
- Applicant
- Alcon
- PMA number
- P950008
- Supplement
- S013
- Product code
- LWL
- Decision date
- 2016-07-18
- Classification
- Fluid, Intraocular
- Generic name
- Fluid, intraocular
- Approval order statement
- Addition of a new biological indicator to be used as an alternate process challenge device (PCD) for terminal sterilization of SILIKON 1000.
Current openFDA PMA Record#
- Device
- SILIKON 1000
- Applicant
- Alcon
- PMA number
- P950008
- Supplement
- S013
- Product code
- LWL
- Generic name
- Fluid, intraocular
- Decision date
- 2016-07-18
- Decision code
- OK30
- Date received
- 2016-06-24
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a new biological indicator to be used as an alternate process challenge device (PCD) for terminal sterilization of SILIKON 1000.