PMA P030028S008
- Device
- Artisan Myopia Intraocular Lens
- Applicant
- Ophtec BV
- PMA number
- P030028
- Supplement
- S008
- Product code
- MTA
- Decision date
- 2019-05-14
- Classification
- Lens, Intraocular, Phakic
- Generic name
- Lens, intraocular, phakic
- Approval order statement
- Approval for minor labeling changes for the Physician’s Labeling and Patient Brochure.
Current openFDA PMA Record#
- Device
- Artisan Myopia Intraocular Lens
- Applicant
- Ophtec BV
- PMA number
- P030028
- Supplement
- S008
- Product code
- MTA
- Generic name
- Lens, intraocular, phakic
- Decision date
- 2019-05-14
- Decision code
- APPR
- Date received
- 2019-02-06
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for minor labeling changes for the Physician’s Labeling and Patient Brochure.