PMA P010019S034

Device
LOTRAFILCON SOFT CONTACT LENSES FOR EXTENDED WEAR
Applicant
Alcon Laboratories, Inc.
PMA number
P010019
Supplement
S034
Product code
LPM
Decision date
2012-10-25
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
MINOR MANUFACTURING CHANGE TO THE METHOD FOR THE MONITORING AND DATAPROCESSING FOR ALL PRODUCTION MODULES OF VARIOUS LENSES.

Current openFDA PMA Record#

Device
LOTRAFILCON SOFT CONTACT LENSES FOR EXTENDED WEAR
Applicant
Alcon Laboratories, Inc.
PMA number
P010019
Supplement
S034
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2012-10-25
Decision code
OK30
Date received
2012-09-27
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
MINOR MANUFACTURING CHANGE TO THE METHOD FOR THE MONITORING AND DATAPROCESSING FOR ALL PRODUCTION MODULES OF VARIOUS LENSES.