PMA P800065S015

Device
LENS-WET(TM)
Applicant
Advanced Medical Optics, Inc.
PMA number
P800065
Supplement
S015
Product code
LPN
Decision date
1996-02-23
Generic name
Accessories, soft lens products
Approval order statement
APPROVAL FOR STERI-TECH, INC., P.O. BOX 1145, SALINAS, PUERTO RICO 00751 AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, TIPS, AND CPAS USED IN THE MANUFACTURE OF THE DEVICE

Current openFDA PMA Record#

Device
LENS-WET(TM)
Applicant
Advanced Medical Optics, Inc.
PMA number
P800065
Supplement
S015
Product code
LPN
Generic name
Accessories, soft lens products
Decision date
1996-02-23
Decision code
APPR
Date received
1995-06-08
Supplement type
Normal 180 Day Track
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR STERI-TECH, INC., P.O. BOX 1145, SALINAS, PUERTO RICO 00751 AS AN ALTERNATE CONTRACT STERILIZATION SITE, AND FOR THE USE OF 100% ETHYLENE OXIDE TO STERILIZE PLASTIC BOTTLES, TIPS, AND CPAS USED IN THE MANUFACTURE OF THE DEVICE