PMA P030016S023

Device
IMPLANTABLE COLLAMER LENS (VISIAN ICL)
Applicant
STAAR Surgical Company
PMA number
P030016
Supplement
S023
Product code
MTA
Decision date
2012-06-08
Classification
Lens, Intraocular, Phakic
Generic name
Lens, intraocular, phakic
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.

Current openFDA PMA Record#

Device
IMPLANTABLE COLLAMER LENS (VISIAN ICL)
Applicant
STAAR Surgical Company
PMA number
P030016
Supplement
S023
Product code
MTA
Generic name
Lens, intraocular, phakic
Decision date
2012-06-08
Decision code
APPR
Date received
2012-02-29
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Postapproval Study Protocol - OSB
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.