| 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 | EXABLATE 2000, VERSION 4.22 |
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| Classification Name | ablation system, high intensity focused ultrasound (hifu), mr-guided |
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| Generic Name | magnetic resonance guidedfocused ultrasound |
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| Applicant | INSIGHTEC, INC. |
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| PMA Number | P040003 |
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| Supplement Number | S004 |
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| Date Received | 04/09/2007 |
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| Decision Date | 08/02/2007 |
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| Product Code | |
| Advisory Committee |
Obstetrics/Gynecology |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | change design/components/specifications - other |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for several hardware enhancements and software error corrections. |
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