PMA P030023S012
- Device
- Capsular Tension Ring (275,276); RingJect (375,376)
- Applicant
- Ophtec BV
- PMA number
- P030023
- Supplement
- S012
- Product code
- MRJ
- Decision date
- 2025-10-06
- Classification
- Ophthalmic
- Generic name
- Ring, endocapsular
- Approval order statement
- addition of an alternative subcontractor for bioburden and endotoxin testing
Current openFDA PMA Record#
- Device
- Capsular Tension Ring (275,276); RingJect (375,376)
- Applicant
- Ophtec BV
- PMA number
- P030023
- Supplement
- S012
- Product code
- MRJ
- Generic name
- Ring, endocapsular
- Decision date
- 2025-10-06
- Decision code
- OK30
- Date received
- 2025-08-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of an alternative subcontractor for bioburden and endotoxin testing