Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device. |
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Trade Name | NEUROCONTROL VOCARE BLADDER SYSTEM |
Classification Name | stimulator, electrical, implantable, for incontinence |
Generic Name | stimulator, electrical, implantable, for incontinence |
Regulation Number | 876.5270 |
Applicant |
MDCI MEDICAL DEVICE CONSULTANTS, INC. |
49 plain st. |
north attleboro, MA 02276-4153 |
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HDE Number | H980008 |
Supplement Number | S002 |
Date Received | 11/17/2004 |
Decision Date | 10/31/2005 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
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