PMA P960011S006

Device: BIOLON(TM) 1% SODIUM HYALURONATE
Applicant: Altacor , Ltd.
PMA number: P960011
Supplement: S006
Product code: LZP
Decision date: 2001-03-08
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: APPROVAL TO CHANGE THE CLEANING IN PLACE AND STERILIZATION IN PLACE PROCESSES AND INTRODUCE AN EQUILIBRATION STEP IN THE MANUFACTURING OF BIOLON(TM).

Current openFDA PMA Record#

Device: BIOLON(TM) 1% SODIUM HYALURONATE
Applicant: Altacor , Ltd.
PMA number: P960011
Supplement: S006
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2001-03-08
Decision code: APPR
Date received: 2000-09-27
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL TO CHANGE THE CLEANING IN PLACE AND STERILIZATION IN PLACE PROCESSES AND INTRODUCE AN EQUILIBRATION STEP IN THE MANUFACTURING OF BIOLON(TM).