Capsular Tension Ring (275,276); RingJect (375,376)
FDA premarket approval P030023/S012 · decided 2025-10-06
Approval details
- PMA number
- P030023
- Supplement
- S012
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Capsular Tension Ring (275,276); RingJect (375,376)
- Generic name
- Ring, endocapsular
- Applicant
- Ophtec BV
- Date received
- 2025-08-27
- Decision date
- 2025-10-06
- Days to decision
- 40 days
- Decision code
- OK30
- Product code
- MRJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Groningen
- Statement
- addition of an alternative subcontractor for bioburden and endotoxin testing
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