PMA P030028S004
- Device
- ARTISAN/Verisyse Myopia Phakic Intraocular Lens (IOL)
- Applicant
- Ophtec BV
- PMA number
- P030028
- Supplement
- S004
- Product code
- MTA
- Decision date
- 2018-08-20
- Classification
- Lens, Intraocular, Phakic
- Generic name
- Lens, intraocular, phakic
- Approval order statement
- Approval for modifying the physician and patient labeling to include the results from the new enrollment post-approval study.
Current openFDA PMA Record#
- Device
- ARTISAN/Verisyse Myopia Phakic Intraocular Lens (IOL)
- Applicant
- Ophtec BV
- PMA number
- P030028
- Supplement
- S004
- Product code
- MTA
- Generic name
- Lens, intraocular, phakic
- Decision date
- 2018-08-20
- Decision code
- APPR
- Date received
- 2017-01-31
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval for modifying the physician and patient labeling to include the results from the new enrollment post-approval study.