PMA P030016S038
- Device
- Visian Toric ICL (Implantable Collamer Lens)
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S038
- Product code
- MTA
- Decision date
- 2019-07-19
- Classification
- Lens, Intraocular, Phakic
- Generic name
- Lens, intraocular, phakic
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- Visian Toric ICL (Implantable Collamer Lens)
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S038
- Product code
- MTA
- Generic name
- Lens, intraocular, phakic
- Decision date
- 2019-07-19
- Decision code
- APPR
- Date received
- 2019-05-21
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the revised protocol for the post-approval study (PAS) protocol.