FDA.reportPublic FDA data

PMA P170007S006

Device
DUROLANE
Applicant
Bioventus, LLC
PMA number
P170007
Supplement
S006
Product code
MOZ
Decision date
2020-10-08
Generic name
Acid, hyaluronic, intraarticular
Approval order statement
Approval for the removal of testing of heavy metals in raw materials for DUROLANE as per USP<231> and replacing it by a risk analysis on the final product based on ICH Q3D Guideline for Elemental Impurities.

Current openFDA PMA Record#

Device
DUROLANE
Applicant
Bioventus, LLC
PMA number
P170007
Supplement
S006
Product code
MOZ
Generic name
Acid, hyaluronic, intraarticular
Decision date
2020-10-08
Decision code
APPR
Date received
2020-04-29
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the removal of testing of heavy metals in raw materials for DUROLANE as per USP and replacing it by a risk analysis on the final product based on ICH Q3D Guideline for Elemental Impurities.