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. |
|
Device | DUROLANE |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | Bioventus LLC 4721 Emperor Blvd, Suite 100 Durham, NC 27703 |
PMA Number | P170007 |
Supplement Number | S014 |
Date Received | 09/14/2022 |
Decision Date | 10/14/2022 |
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 Installation of a new point of use and a higher capacity centrifugal water pump for a Water for Injection (WFI) system used in the manufacturing of DUROLANE. |
|
|