PMA P030016S029
- Device
- VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA (MICL)
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S029
- Product code
- MTA
- Decision date
- 2015-12-10
- Classification
- Lens, Intraocular, Phakic
- Generic name
- Lens, intraocular, phakic
- Approval order statement
- TO ADD THE GETINGE AUTOCLAVE AS AN ALTERNATE STERILIZER FOR THE VISIAN LENS.
Current openFDA PMA Record#
- Device
- VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA (MICL)
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S029
- Product code
- MTA
- Generic name
- Lens, intraocular, phakic
- Decision date
- 2015-12-10
- Decision code
- OK30
- Date received
- 2015-11-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- TO ADD THE GETINGE AUTOCLAVE AS AN ALTERNATE STERILIZER FOR THE VISIAN LENS.