Capsular Tension Ring (CTR) and RingJect
FDA premarket approval P030023/S009 · decided 2024-08-01
Approval details
- PMA number
- P030023
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Capsular Tension Ring (CTR) and RingJect
- Generic name
- Ring, endocapsular
- Applicant
- Ophtec BV
- Date received
- 2022-03-30
- Decision date
- 2024-08-01
- Days to decision
- 855 days
- Decision code
- APPR
- Product code
- MRJ
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Groningen
- Statement
- approval for a manufacturing site located at Sterigenics Germany GmbH, FEI 3006003617, Kasteler Str. 45 Wiesbaden Hesse, 65203, Germany, for Ethylene Oxide Sterilization of Capsular Tension Ring (CTS) and RingJect.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.