PMA P100016S002

Device
EC-3 AND EC-3 PRECISION ASPHERIC LENS (PAL)IOLS
Applicant
Carl Zeiss Meditec Production, LLC
PMA number
P100016
Supplement
S002
Product code
HQL
Decision date
2015-04-13
Classification
Intraocular Lens
Generic name
intraocular lens
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED IN ONTARIO, CALIFORNIA.

Current openFDA PMA Record#

Device
EC-3 AND EC-3 PRECISION ASPHERIC LENS (PAL)IOLS
Applicant
Carl Zeiss Meditec Production, LLC
PMA number
P100016
Supplement
S002
Product code
HQL
Generic name
intraocular lens
Decision date
2015-04-13
Decision code
APPR
Date received
2014-12-18
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING SITE LOCATED IN ONTARIO, CALIFORNIA.