PMA P100016S012
- Device
- CT Lucia 602, CT Lucia 202, CT Lucia 611P
- Applicant
- Carl Zeiss Meditec Production, LLC
- PMA number
- P100016
- Supplement
- S012
- Product code
- HQL
- Decision date
- 2022-03-25
- Generic name
- intraocular lens
- Approval order statement
- Addition of validated ethylene oxide sterilization Chamber #9 with its validated Cycle #834 to the routine sterilization process.
Current openFDA PMA Record#
- Device
- CT Lucia 602, CT Lucia 202, CT Lucia 611P
- Applicant
- Carl Zeiss Meditec Production, LLC
- PMA number
- P100016
- Supplement
- S012
- Product code
- HQL
- Generic name
- intraocular lens
- Decision date
- 2022-03-25
- Decision code
- OK30
- Date received
- 2022-03-03
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of validated ethylene oxide sterilization Chamber #9 with its validated Cycle #834 to the routine sterilization process.