PMA P100016S011

Device
CT Lucia 602
Applicant
Carl Zeiss Meditec Production, LLC
Product code
HQL
Decision date
2022-07-14
Generic name
intraocular lens
Approval order statement
Approval for qualifying a new package tester.

Current openFDA PMA Record#

Device
CT Lucia 602
Applicant
Carl Zeiss Meditec Production, LLC
PMA number
P100016
Supplement
S011
Product code
HQL
Generic name
intraocular lens
Decision date
2022-07-14
Decision code
APPR
Date received
2022-03-03
Supplement type
135 Review Track For 30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for qualifying a new package tester.