PMA P860047S022

Device
OCUCOAT
Applicant
Bausch & Lomb, Inc.
PMA number
P860047
Supplement
S022
Product code
LZP
Decision date
2008-07-16
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
USE OF AN ALTERNATE STERILIZATION CHANGE AT THE STERIS-ISOMEDIX FACILITY.

Current openFDA PMA Record#

Device
OCUCOAT
Applicant
Bausch & Lomb, Inc.
PMA number
P860047
Supplement
S022
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2008-07-16
Decision code
OK30
Date received
2008-06-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
USE OF AN ALTERNATE STERILIZATION CHANGE AT THE STERIS-ISOMEDIX FACILITY.