PMA P010019S037

Device
LOTRAFILCON A SOFT CONTACT LENSES
Applicant
Alcon Laboratories, Inc.
PMA number
P010019
Supplement
S037
Product code
LPM
Decision date
2015-04-02
Classification
Lenses, Soft Contact, Extended Wear
Generic name
Lenses, soft contact, extended wear
Approval order statement
ALTERNATE LENS WATER CONTENT MEASUREMENT PROCEDURE AT ALCONS BATAM, INDONESIA MANUFACTURING SITE.

Current openFDA PMA Record#

Device
LOTRAFILCON A SOFT CONTACT LENSES
Applicant
Alcon Laboratories, Inc.
PMA number
P010019
Supplement
S037
Product code
LPM
Generic name
Lenses, soft contact, extended wear
Decision date
2015-04-02
Decision code
OK30
Date received
2015-03-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE LENS WATER CONTENT MEASUREMENT PROCEDURE AT ALCONS BATAM, INDONESIA MANUFACTURING SITE.