| 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 | DEFLUX INJECTABLE GEL |
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| Classification Name | agent, bulking, injectable for gastro-urology use |
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| Generic Name | injectable bulking agent |
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| Applicant | Q-MED SCANDINAVIA, INC. |
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| PMA Number | P000029 |
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| Supplement Number | S017 |
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| Date Received | 03/06/2006 |
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| Decision Date | 03/28/2008 |
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| Product Code | |
| Advisory Committee |
Gastroenterology |
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| Supplement Type | normal 180 day track no user fee |
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| Supplement Reason | location change: manufacturer |
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| Expedited Review Granted? | No |
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Approval Order Statement
Approval for a manufacturing site located at q-med ab, uppsala, sweden, to test for heavy metals and analysis of nitrates. |
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