PMA P860047S023

Device
OCUCOAT
Applicant
Bausch & Lomb, Inc.
PMA number
P860047
Supplement
S023
Product code
LZP
Decision date
2009-12-02
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
CHANGE IN THE BIOLOGICAL INDICATOR TESTING SITE FROM ALLIANCE MEDICAL PRODUCTS IN IRVINE, CALIFORNIA TO THE BAUSCH & LOMB FACILITY IN TAMPA, FLORIDA.

Current openFDA PMA Record#

Device
OCUCOAT
Applicant
Bausch & Lomb, Inc.
PMA number
P860047
Supplement
S023
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2009-12-02
Decision code
OK30
Date received
2009-11-02
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN THE BIOLOGICAL INDICATOR TESTING SITE FROM ALLIANCE MEDICAL PRODUCTS IN IRVINE, CALIFORNIA TO THE BAUSCH & LOMB FACILITY IN TAMPA, FLORIDA.