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. |
|
Device | GENVISC 850 |
Generic Name | Acid, hyaluronic, intraarticular |
Applicant | ORTHOGENRX,INC 2005 South Easton Road Suite 207 Doylestown, PA 18901 |
PMA Number | P140005 |
Date Received | 04/16/2014 |
Decision Date | 09/02/2015 |
Product Code |
MOZ |
Docket Number | 15M-3258 |
Notice Date | 10/15/2015 |
Advisory Committee |
Orthopedic |
Clinical Trials | NCT00669032
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR GENVISC 850®. THIS DEVICE IS INDICATED FOR OR THE TREATMENT OF PAIN IN OSTEOARTHRITIS (OA) OF THE KNEE IN PATIENTS WHO HAVE FAILED TO RESPOND ADEQUATELY TO CONSERVATIVE NON-PHARMACOLOGIC THERAPY AND SIMPLE ANALGESICS, E.G., ACETAMINOPHEN. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Supplements: |
S004 S005 |
|
|