PMA P810025S024

Device
AMVISC & AMVISC PLUS
Applicant
Bausch & Lomb, Inc.
PMA number
P810025
Supplement
S024
Product code
LZP
Decision date
2004-07-16
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
ELIMINATION OF THE OWL MONKEY TEST FOR INFLAMMATORY POTENTIAL OF BULK AND FINISHED PRODUCT FORMULATION OF AMVISC & AMVISC PLUS.

Current openFDA PMA Record#

Device
AMVISC & AMVISC PLUS
Applicant
Bausch & Lomb, Inc.
PMA number
P810025
Supplement
S024
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2004-07-16
Decision code
OK30
Date received
2004-06-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ELIMINATION OF THE OWL MONKEY TEST FOR INFLAMMATORY POTENTIAL OF BULK AND FINISHED PRODUCT FORMULATION OF AMVISC & AMVISC PLUS.