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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 | S001 |
Date Received | 01/07/2000 |
Decision Date | 01/10/2000 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for replacing the current mri (magnetic resonance imaging) warning in the labeling with a precaution statement. |