PMA P960011S009

Device: BIOLON (1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)
Applicant: Altacor , Ltd.
PMA number: P960011
Supplement: S009
Product code: LZP
Decision date: 2005-01-27
Classification: Aid, Surgical, Viscoelastic
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: APPROVAL FOR A CHANGE IN MANUFACTURING SITE TO THE BIO-TECHNOLOGY GENERAL, LTD. FACILITY IN BE'ER TUVIA, ISRAEL, AND FOR A CHANGE IN THE SPECIFICATIONS FOR THE ACTIVE PHARMACEUTICAL PRODUCT IN BIOLON.

Current openFDA PMA Record#

Device: BIOLON (1% SODIUM HYALURONATE FOR OPHTHALMIC SURGERY)
Applicant: Altacor , Ltd.
PMA number: P960011
Supplement: S009
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2005-01-27
Decision code: APPR
Date received: 2004-07-09
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR A CHANGE IN MANUFACTURING SITE TO THE BIO-TECHNOLOGY GENERAL, LTD. FACILITY IN BE'ER TUVIA, ISRAEL, AND FOR A CHANGE IN THE SPECIFICATIONS FOR THE ACTIVE PHARMACEUTICAL PRODUCT IN BIOLON.