PMA P030028S013
- Device
- ARTISAN Myopia Models 204US1W and 206US1W
- Applicant
- Ophtec BV
- PMA number
- P030028
- Supplement
- S013
- Product code
- MTA
- Decision date
- 2026-04-24
- Classification
- Ophthalmic
- Generic name
- Lens, intraocular, phakic
- Approval order statement
- the addition of an alternative third-party testing laboratory for routine bioburden and endotoxin quality control testing
Current openFDA PMA Record#
- Device
- ARTISAN Myopia Models 204US1W and 206US1W
- Applicant
- Ophtec BV
- PMA number
- P030028
- Supplement
- S013
- Product code
- MTA
- Generic name
- Lens, intraocular, phakic
- Decision date
- 2026-04-24
- Decision code
- OK30
- Date received
- 2025-11-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- the addition of an alternative third-party testing laboratory for routine bioburden and endotoxin quality control testing