DUROLANE

FDA Premarket Approval P170007 S006

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

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.

DeviceDUROLANE
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantBioventus LLC
Date Received2020-04-29
Decision Date2020-10-08
PMAP170007
SupplementS006
Product CodeMOZ 
Advisory CommitteeOrthopedic
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address Bioventus LLC 4721 Emperor Blvd, Suite 100 durham, NC 27703

Supplemental Filings

Supplement NumberDateSupplement Type
P170007Original Filing
S008 2020-09-23 30-day Notice
S007
S006 2020-04-29 Real-time Process
S005 2019-11-18 30-day Notice
S004 2019-08-20 30-day Notice
S003 2019-05-09 30-day Notice
S002 2019-02-06 30-day Notice
S001 2018-07-19 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00816986020808 P170007 000
00816986020808 P170007 000
00816986020808 P170007 000
05060548950071 P170007 001

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