• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
Trade NameNEUROCONTROL VOCARE BLADDER SYSTEM
Classification Nameelectrical stimulation bladder system
Generic Nameelectrical stimulation bladder system
Applicant
MDCI MEDICAL DEVICE CONSULTANTS, INC.
49 plain st.
north attleboro, MA 02276-4153
HDE NumberH980008
Date Received12/08/1998
Decision Date02/19/1999
Product Code
PAZ
Docket Number 99M-0255
Advisory Committee Gastroenterology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
For vocare(r) bladder system, for the secondary indication for use of "to aid in bowel evacuation. ".
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Supplements: S001 S002 
-
-