PMA P810025S028

Device: AMVISC & AMVISC PLUS
Applicant: Bausch & Lomb, Inc.
PMA number: P810025
Supplement: S028
Product code: LZP
Decision date: 2012-05-15
Generic name: AID, SURGICAL, VISCOELASTIC
Approval order statement: APPROVAL FOR AN ALTERNATE RAW MATERIAL SOURCE (LIFECORES FERMENTATION-BASED SODIUM HYALURONATE) AND ALTERNATE MANUFACTURING SITE (LIFECORE BIOMEDICAL, LLC, CHASKA, MN) FOR RAW MATERIAL AND FINISHED PRODUCTS.

Current openFDA PMA Record#

Device: AMVISC & AMVISC PLUS
Applicant: Bausch & Lomb, Inc.
PMA number: P810025
Supplement: S028
Product code: LZP
Generic name: AID, SURGICAL, VISCOELASTIC
Decision date: 2012-05-15
Decision code: APPR
Date received: 2010-06-21
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR AN ALTERNATE RAW MATERIAL SOURCE (LIFECORES FERMENTATION-BASED SODIUM HYALURONATE) AND ALTERNATE MANUFACTURING SITE (LIFECORE BIOMEDICAL, LLC, CHASKA, MN) FOR RAW MATERIAL AND FINISHED PRODUCTS.