Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device. |
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Trade Name | URO-STIM THERAPEUTIC STIMULATION UNIT |
Classification Name | stimulator, bladder |
Generic Name | stimulator, bladder |
Applicant |
WILLIAM E. KAPLAN, M.D. |
2300 children's plaza, #24 |
chicago, IL 60614 |
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HDE Number | H970003 |
Date Received | 09/12/1997 |
Decision Date | 12/16/1997 |
Product Code | |
Docket Number | 98M-0163 |
Advisory Committee |
Gastroenterology |
Supplement Type | hde original |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the urostim. This device is indicated for use in children for the treatment of neurogenic bladder disease secondary to spina bifida. |
Approval Order | Approval Order |
Supplements: |
S001 |
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