Durolane

Acid, Hyaluronic, Intraarticular

FDA Premarket Approval P170007 S004

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

Extension of the designated shelf life of the ha raw material used in the manufacture of durolane

DeviceDurolane
Classification NameAcid, Hyaluronic, Intraarticular
Generic NameAcid, Hyaluronic, Intraarticular
ApplicantBioventus LLC
Date Received2019-08-20
Decision Date2019-09-19
PMAP170007
SupplementS004
Product CodeMOZ
Advisory CommitteeOrthopedic
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Bioventus LLC 4721 Emperor Blvd, Suite 100 durham, NC 27703

Supplemental Filings

Supplement NumberDateSupplement Type
P170007Original Filing
S014 2022-09-14 30-day Notice
S013 2022-02-03 30-day Notice
S012 2022-02-03 30-day Notice
S011 2022-01-06 30-day Notice
S010 2021-08-04 30-day Notice
S009 2021-04-28 30-day Notice
S008 2020-09-23 30-day Notice
S007 2020-09-01 Normal 180 Day Track
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
05060548950071 P170007 001

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