PMA P030016S030
- Device
- VISIAN ICL (IMPLANTABLE COLLAMER LENS) FOR MYOPIA
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S030
- Product code
- MTA
- Decision date
- 2017-01-25
- Classification
- Lens, Intraocular, Phakic
- Generic name
- Lens, intraocular, phakic
- Approval order statement
- Manufacture of an in-process aid at the STAAR Monrovia, CA manufacturing site as an alternative to the current supplier.
Current openFDA PMA Record#
- Device
- VISIAN ICL (IMPLANTABLE COLLAMER LENS) FOR MYOPIA
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S030
- Product code
- MTA
- Generic name
- Lens, intraocular, phakic
- Decision date
- 2017-01-25
- Decision code
- OK30
- Date received
- 2017-01-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Manufacture of an in-process aid at the STAAR Monrovia, CA manufacturing site as an alternative to the current supplier.