PMA P810025S030

Device
AMVISC/AMVISC PLUS (OPHTHALMIC VISCOSURGICAL DEVICES)
Applicant
Bausch & Lomb, Inc.
PMA number
P810025
Supplement
S030
Product code
LZP
Decision date
2010-12-01
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
CHANGE IN RAW MATERIAL SAMPLE PREPARATION FOR ENDOTOXIN TESTING.

Current openFDA PMA Record#

Device
AMVISC/AMVISC PLUS (OPHTHALMIC VISCOSURGICAL DEVICES)
Applicant
Bausch & Lomb, Inc.
PMA number
P810025
Supplement
S030
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2010-12-01
Decision code
OK30
Date received
2010-11-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
CHANGE IN RAW MATERIAL SAMPLE PREPARATION FOR ENDOTOXIN TESTING.