PMA P960011S003

Device: BIOLON 1% SODIUM HYALURONATE
Applicant: Altacor , Ltd.
PMA number: P960011
Supplement: S003
Product code: LZP
Decision date: 1999-09-02
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: The 30-Day Notice requested a manufacturing process change for BioLon(TM) (1% sodium hyaluronate). The requested change describes the installation and qualification of an upgrade to Bio-Technology General Corporation's fermentation process at the Rehovot, Israel facility and the validation of the sodium hyaluronate fermentation process after the upgrade.

Current openFDA PMA Record#

Device: BIOLON 1% SODIUM HYALURONATE
Applicant: Altacor , Ltd.
PMA number: P960011
Supplement: S003
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 1999-09-02
Decision code: OK30
Date received: 1999-08-03
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: The 30-Day Notice requested a manufacturing process change for BioLon(TM) (1% sodium hyaluronate). The requested change describes the installation and qualification of an upgrade to Bio-Technology General Corporation's fermentation process at the Rehovot, Israel facility and the validation of the sodium hyaluronate fermentation process after the upgrade.