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Device | ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | Anika Therapeutics, Inc. 32 WIGGINS AVENUE BEDFORD, MA 01730 |
PMA Number | P030019 |
Date Received | 05/30/2003 |
Decision Date | 02/04/2004 |
Product Code |
MOZ |
Docket Number | 06M-0339 |
Notice Date | 08/24/2006 |
Advisory Committee |
Orthopedic |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE ORTHOVISC HIGH MOLECULAR WEIGHT HYALURONAN. THE DEVICE IS INDICATED FO THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND TO SIMPLE ANALGESICS (E.G., ACETAMINOPHEN). |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Supplements: |
S001 S003 S004 S005 S006 S008 S009 S010 S012 S013 S014 S015 S017 S018 S019 S020 S021 S022 S023 S025 S026 S027 |