PMA P030016S018
- Device
- STAAR SURGICAL IMPLANTABLE COLLAMER LENS (VISIAN ICL)
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S018
- Product code
- MTA
- Decision date
- 2011-04-08
- Classification
- Lens, Intraocular, Phakic
- Generic name
- Lens, intraocular, phakic
- Approval order statement
- APPROVAL FOR A LABELING MODIFICATION TO REFLECT RESULTS FROM AN AXIAL LENGTH POST-APPROVAL STUDY PROTOCOL.
Current openFDA PMA Record#
- Device
- STAAR SURGICAL IMPLANTABLE COLLAMER LENS (VISIAN ICL)
- Applicant
- STAAR Surgical Company
- PMA number
- P030016
- Supplement
- S018
- Product code
- MTA
- Generic name
- Lens, intraocular, phakic
- Decision date
- 2011-04-08
- Decision code
- APPR
- Date received
- 2010-10-14
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- APPROVAL FOR A LABELING MODIFICATION TO REFLECT RESULTS FROM AN AXIAL LENGTH POST-APPROVAL STUDY PROTOCOL.