| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | MONOVISC |
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| Generic Name | Acid, hyaluronic, intraarticular |
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| Applicant | Anika Therapeutics, Inc.
32 WIGGINS AVENUE
BEDFORD, MA 01730 |
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| PMA Number | P090031 |
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| Date Received | 12/29/2009 |
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| Decision Date | 02/25/2014 |
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| Product Code |
MOZ |
| Docket Number | 14M-0254 |
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| Notice Date | 03/05/2014 |
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| Advisory Committee |
Orthopedic |
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| Clinical Trials | NCT00653432
|
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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Approval Order Statement
APPROVAL FOR THE MONOVISC INJECTABLE INTRA-ARTICULAR DEVICE. THIS DEVICE IS INDICATED FOR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TOCONSERVATIVE NON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN). |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Supplements: |
S001 S002 S003 S004 S006 S007 S008 S009 S010 S011 S012
S013 S014 S015 S016 |
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