PMA P840064S042

Device
DISCOVISC, VISCOAT, AND DUOVISC
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S042
Product code
LZP
Decision date
2010-06-16
Classification
Aid, Surgical, Viscoelastic
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
EXPANSION OF THE USE OF A PREVIOUSLY APPROVED CLEANROOM FOR ASEPTIC FILLING TO INCLUDE ASEPTIC COMPOUNDING.

Current openFDA PMA Record#

Device
DISCOVISC, VISCOAT, AND DUOVISC
Applicant
Alcon Laboratories
PMA number
P840064
Supplement
S042
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2010-06-16
Decision code
OK30
Date received
2010-05-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
EXPANSION OF THE USE OF A PREVIOUSLY APPROVED CLEANROOM FOR ASEPTIC FILLING TO INCLUDE ASEPTIC COMPOUNDING.