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 | Monovisc High Molecular Weight Hyaluronan |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | Anika Therapeutics, Inc. 32 WIGGINS AVENUE BEDFORD, MA 01730 |
PMA Number | P090031 |
Supplement Number | S015 |
Date Received | 10/12/2022 |
Decision Date | 11/08/2022 |
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 Addition of an alternate supplier of fermented hyaluronic acid (HA) raw material for Orthovisc and Monovisc. |
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