PMA P960012S001

Device
REFRESH CL(TM)/LUBRICATING AND REWETING DROPS
Applicant
Abbott Medical Optics, Inc.
PMA number
P960012
Supplement
S001
Product code
LPN
Decision date
1997-04-24
Generic name
Accessories, soft lens products
Approval order statement
APPROVAL TO ADD RIGID GAS PERMEABLE CONTACT LENSES TO THE LABEL INDICATIONS.

Current openFDA PMA Record#

Device
REFRESH CL(TM)/LUBRICATING AND REWETING DROPS
Applicant
Abbott Medical Optics, Inc.
PMA number
P960012
Supplement
S001
Product code
LPN
Generic name
Accessories, soft lens products
Decision date
1997-04-24
Decision code
APPR
Date received
1996-12-23
Supplement type
Normal 180 Day Track
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL TO ADD RIGID GAS PERMEABLE CONTACT LENSES TO THE LABEL INDICATIONS.