PMA P030028S002
- Device
- ARTISAN MYOPIA PHAKIC IOL
- Applicant
- Ophtec BV
- PMA number
- P030028
- Supplement
- S002
- Product code
- MTA
- Decision date
- 2010-11-23
- Classification
- Lens, Intraocular, Phakic
- Generic name
- Lens, intraocular, phakic
- Approval order statement
- SHORTENING OF ETHYLENE OXIDE DEGASSING PHASE PROCESS AND THE ADDITION OF AN ADDITIONAL STERILIZATION CONFIGURATION.
Current openFDA PMA Record#
- Device
- ARTISAN MYOPIA PHAKIC IOL
- Applicant
- Ophtec BV
- PMA number
- P030028
- Supplement
- S002
- Product code
- MTA
- Generic name
- Lens, intraocular, phakic
- Decision date
- 2010-11-23
- Decision code
- OK30
- Date received
- 2010-10-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- SHORTENING OF ETHYLENE OXIDE DEGASSING PHASE PROCESS AND THE ADDITION OF AN ADDITIONAL STERILIZATION CONFIGURATION.