Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: 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.
 
DeviceDUROLANE
Generic NameAcid, hyaluronic, intraarticular
ApplicantBioventus, LLC
4721 Emperor Blvd., Suite 100
Durham, NC 27703
PMA NumberP170007
Supplement NumberS006
Date Received04/29/2020
Decision Date10/08/2020
Product Code MOZ 
Advisory Committee Orthopedic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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.
-
-