PMA P030016S046
- Device
- Visian ICL (Implantable Collamer Lens), Visian Toric ICL (Implantable Collamer Lens), Visian EVO/EVO+ ICL (Implantable C
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S046
- Product code
- MTA
- Decision date
- 2024-05-10
- Classification
- Ophthalmic
- Generic name
- Lens, intraocular, phakic
- Approval order statement
- addition of a new manufacturing room at the current manufacturing site
Current openFDA PMA Record#
- Device
- Visian ICL (Implantable Collamer Lens), Visian Toric ICL (Implantable Collamer Lens), Visian EVO/EVO+ ICL (Implantable C
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S046
- Product code
- MTA
- Generic name
- Lens, intraocular, phakic
- Decision date
- 2024-05-10
- Decision code
- OK30
- Date received
- 2024-05-01
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- addition of a new manufacturing room at the current manufacturing site