PMA P030028S001

Device
ARTISAN/VERISYSE PHAKIC IOL
Applicant
Ophtec BV
PMA number
P030028
Supplement
S001
Product code
MTA
Decision date
2011-11-09
Classification
Lens, Intraocular, Phakic
Generic name
Lens, intraocular, phakic
Approval order statement
APPROVAL OF THE POST-APPROVAL STUDY PROTOCOL.

Current openFDA PMA Record#

Device
ARTISAN/VERISYSE PHAKIC IOL
Applicant
Ophtec BV
PMA number
P030028
Supplement
S001
Product code
MTA
Generic name
Lens, intraocular, phakic
Decision date
2011-11-09
Decision code
APPR
Date received
2009-11-25
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.