PMA P060011S009

Device
C-FLEX MODEL 570C INTRAOCULAR LENS (IOL)
Applicant
Rayner Intraocular Lenses , Ltd.
PMA number
P060011
Supplement
S009
Product code
HQL
Decision date
2016-06-08
Classification
Intraocular Lens
Generic name
intraocular lens
Approval order statement
Introduction of a new standard blister pouch for the Rayner C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular lenses.

Current openFDA PMA Record#

Device
C-FLEX MODEL 570C INTRAOCULAR LENS (IOL)
Applicant
Rayner Intraocular Lenses , Ltd.
PMA number
P060011
Supplement
S009
Product code
HQL
Generic name
intraocular lens
Decision date
2016-06-08
Decision code
OK30
Date received
2016-05-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Introduction of a new standard blister pouch for the Rayner C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular lenses.