| Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device. |
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| Trade Name | SYNVISC-ONE |
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| Classification Name | acid, hyaluronic, intraarticular |
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| Generic Name | hylan g-f 20 |
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| Applicant | GENZYME CORP. |
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| PMA Number | P940015 |
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| Supplement Number | S012 |
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| Date Received | 06/19/2007 |
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| Decision Date | 02/26/2009 |
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| Product Code | |
| Docket Number | 09M-0128 |
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| Notice Date | 03/10/2009 |
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| Advisory Committee |
Orthopedic |
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| Supplement Type | panel track |
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| Supplement Reason | labeling change - indications |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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| Information About: |
Labeling, Approval Order, Summary of Safety and Effectiveness |
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Approval Order Statement
Approval for the synvisc-one. The device is indicated for the treatment of pain in osteoarthritis of the knee in patients who have filed to respond adequately to conservative non-pharmacologic therapy and simple analgesics, e. G. , acetaminophen. |
| Approval Order |
Approval Order
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