PMA P030028S012
- Device
- ARTISAN Phakic lntraocular Lens (IOL),
- Applicant
- Ophtec BV
- PMA number
- P030028
- Supplement
- S012
- Product code
- MTA
- Decision date
- 2024-01-18
- Classification
- Ophthalmic
- Generic name
- Lens, intraocular, phakic
- Approval order statement
- a change to the supplier of the packaging Tyvek lid
Current openFDA PMA Record#
- Device
- ARTISAN Phakic lntraocular Lens (IOL),
- Applicant
- Ophtec BV
- PMA number
- P030028
- Supplement
- S012
- Product code
- MTA
- Generic name
- Lens, intraocular, phakic
- Decision date
- 2024-01-18
- Decision code
- OK30
- Date received
- 2023-12-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- a change to the supplier of the packaging Tyvek lid