| 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 | PROSTATRON |
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| Classification Name | system, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
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| Generic Name | prostate (bph) microwave apparatus |
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| Applicant | EDAP TECHNOMED, INC. |
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| PMA Number | P950014 |
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| Supplement Number | S008 |
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| Date Received | 08/28/1997 |
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| Decision Date | 11/07/1997 |
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| Product Code | |
| Advisory Committee |
Gastroenterology/Urology |
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| Supplement Type | normal 180 day track |
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| Supplement Reason | location change: sterilizer |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval for a new sterilization facility located at griffith micro science, 8 rue de parmentier, 60290 rantigny, france. |
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