PMA P060011S013

Device
Rayner C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular Lenses
Applicant
Rayner Intraocular Lenses , Ltd.
PMA number
P060011
Supplement
S013
Product code
HQL
Decision date
2017-12-07
Classification
Intraocular Lens
Generic name
intraocular lens
Approval order statement
Addition of a supplier for repackaging the device into the approved configuration.

Current openFDA PMA Record#

Device
Rayner C-flex 570C, C-flex Aspheric 970C and 600C Aspheric Intraocular Lenses
Applicant
Rayner Intraocular Lenses , Ltd.
PMA number
P060011
Supplement
S013
Product code
HQL
Generic name
intraocular lens
Decision date
2017-12-07
Decision code
OK30
Date received
2017-11-13
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Addition of a supplier for repackaging the device into the approved configuration.