PMA P960011S008

Device
BIOLON(1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)
Applicant
Altacor , Ltd.
PMA number
P960011
Supplement
S008
Product code
LZP
Decision date
2002-04-01
Classification
Aid, Surgical, Viscoelastic
Generic name
AID, SURGICAL, VISCOELASTIC
Approval order statement
APPROVAL FOR AN ALTERNATE STERILIZATION AND FINAL CARTONING FACILITY LOCATED AT MEDICAL MANUFACTURING CORPORATION, ERIE, PENNSYLVANIA.

Current openFDA PMA Record#

Device
BIOLON(1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)
Applicant
Altacor , Ltd.
PMA number
P960011
Supplement
S008
Product code
LZP
Generic name
AID, SURGICAL, VISCOELASTIC
Decision date
2002-04-01
Decision code
APPR
Date received
2002-03-18
Supplement type
Normal 180 Day Track
Supplement reason
Express GMP Supplement
Approval order statement
APPROVAL FOR AN ALTERNATE STERILIZATION AND FINAL CARTONING FACILITY LOCATED AT MEDICAL MANUFACTURING CORPORATION, ERIE, PENNSYLVANIA.