RingJect and Capsular Tension Ring (CTR)
FDA premarket approval P030023/S008 · decided 2022-07-21
Approval details
- PMA number
- P030023
- Supplement
- S008
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- RingJect and Capsular Tension Ring (CTR)
- Generic name
- Ring, endocapsular
- Applicant
- Ophtec BV
- Date received
- 2022-02-08
- Decision date
- 2022-07-21
- Days to decision
- 163 days
- Decision code
- OK30
- Product code
- MRJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Groningen
- Statement
- Change to the processing agent used in the milling process for the Capsular Tension Ring (CTR) and RingJect.
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