PMA P030023S008
- Device
- RingJect and Capsular Tension Ring (CTR)
- Applicant
- Ophtec BV
- PMA number
- P030023
- Supplement
- S008
- Product code
- MRJ
- Decision date
- 2022-07-21
- Generic name
- Ring, endocapsular
- Approval order statement
- Change to the processing agent used in the milling process for the Capsular Tension Ring (CTR) and RingJect.
Current openFDA PMA Record#
- Device
- RingJect and Capsular Tension Ring (CTR)
- Applicant
- Ophtec BV
- PMA number
- P030023
- Supplement
- S008
- Product code
- MRJ
- Generic name
- Ring, endocapsular
- Decision date
- 2022-07-21
- Decision code
- OK30
- Date received
- 2022-02-08
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change to the processing agent used in the milling process for the Capsular Tension Ring (CTR) and RingJect.