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. |
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Device | Durolane, Hyaluronic Acid, Stabilized Single Injection |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | Bioventus LLC 4721 Emperor Blvd, Suite 100 Durham, NC 27703 |
PMA Number | P170007 |
Supplement Number | S003 |
Date Received | 05/09/2019 |
Decision Date | 06/08/2019 |
Product Code |
MOZ |
Advisory Committee |
Orthopedic |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Alternative source of the sodium chloride solution utilized in the manufacture of DUROLANE. |
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