- Device
- EVO Visian Implantable Collamer Lens for Myopia (VICMO), EVO Visian Toric Implantable Collamer Lens for Myopia (VTICMO),
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S045
- Product code
- MTA
- Generic name
- Lens, intraocular, phakic
- Decision date
- 2024-10-01
- Decision code
- APPR
- Date received
- 2024-04-12
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- approval for labeling updates related to PAS “CP22-01 Postmarket Evaluation of the EVO ICL"