| 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 INTERNATIONAL CORP. |
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| PMA Number | P950014 |
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| Supplement Number | S001 |
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| Date Received | 05/16/1996 |
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| Decision Date | 06/20/1996 |
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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 | process change: sterilization |
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| Expedited Review Granted? | No |
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| Combination Product |
No
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Approval Order Statement
Approval to supply the prostatron treatment catheter (i. E. , the prostaprobe) in sterile form. |
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