Premarket Approval (PMA)

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: Monovisc High Molecular Weight Hyaluronan
• Generic Name: Acid, hyaluronic, intraarticular
• Applicant: Anika Therapeutics, Inc.; 32 Wiggins Ave.; Beford, MA 01730
• PMA Number: P090031
• Supplement Number: S010
• Date Received: 08/11/2021
• Decision Date: 09/03/2021
• 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
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Alternate supplier of the glass syringes used in manufacture of the 5mL sizes of Monovisc.