FDA.reportPublic FDA data

PMA P010019S063

Device
Lotrafilcon A Soft Contact Lenses for Extended Wear
Applicant
Alcon Laboratories, Inc.
PMA number
P010019
Supplement
S063
Product code
LPM
Decision date
2018-03-02
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
Startup of lotrafilcon A back end finishing production at the Johor, Malaysia facility including technology transfer from the Batam Indonesia manufacturing facility to the production facility in Johor, Malaysia.

Current openFDA PMA Record#

Device
Lotrafilcon A Soft Contact Lenses for Extended Wear
Applicant
Alcon Laboratories, Inc.
PMA number
P010019
Supplement
S063
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2018-03-02
Decision code
OK30
Date received
2018-02-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Startup of lotrafilcon A back end finishing production at the Johor, Malaysia facility including technology transfer from the Batam Indonesia manufacturing facility to the production facility in Johor, Malaysia.