PMA P030023S009

Device: Capsular Tension Ring (CTR) and RingJect
Applicant: Ophtec BV
PMA number: P030023
Supplement: S009
Product code: MRJ
Decision date: 2024-08-01
Classification: Ophthalmic
Generic name: Ring, endocapsular
Approval order 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.

Current openFDA PMA Record#

Device: Capsular Tension Ring (CTR) and RingJect
Applicant: Ophtec BV
PMA number: P030023
Supplement: S009
Product code: MRJ
Generic name: Ring, endocapsular
Decision date: 2024-08-01
Decision code: APPR
Date received: 2022-03-30
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.