PMA P030016S017
- Device
- VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S017
- Product code
- MTA
- Decision date
- 2010-09-15
- Classification
- Lens, Intraocular, Phakic
- Generic name
- Lens, intraocular, phakic
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE DIRECTIONS FOR USE TO INCLUDE A WARNING STATEMENT AND A MODIFICATION TO A CONTRAINDICATION.
Current openFDA PMA Record#
- Device
- VISIAN IMPLANTABLE COLLAMER LENS FOR MYOPIA
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S017
- Product code
- MTA
- Generic name
- Lens, intraocular, phakic
- Decision date
- 2010-09-15
- Decision code
- APPR
- Date received
- 2010-08-17
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR A MODIFICATION TO THE DIRECTIONS FOR USE TO INCLUDE A WARNING STATEMENT AND A MODIFICATION TO A CONTRAINDICATION.