PMA P030023S007
- Device
- Capsular Tension Ring (CTR)
- Applicant
- Ophtec BV
- PMA number
- P030023
- Supplement
- S007
- Product code
- MRJ
- Decision date
- 2019-03-27
- Classification
- Ring, Endocapsular
- Generic name
- Ring, endocapsular
- Approval order statement
- Ethylene oxide sterilization cycle improvements for 1 full sterilization cycle for the Artisan Myopia Intraocular Lenses sterilized at AT Sterigenics in Belgium.
Current openFDA PMA Record#
- Device
- Capsular Tension Ring (CTR)
- Applicant
- Ophtec BV
- PMA number
- P030023
- Supplement
- S007
- Product code
- MRJ
- Generic name
- Ring, endocapsular
- Decision date
- 2019-03-27
- Decision code
- OK30
- Date received
- 2018-12-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Ethylene oxide sterilization cycle improvements for 1 full sterilization cycle for the Artisan Myopia Intraocular Lenses sterilized at AT Sterigenics in Belgium.