Humanitarian Device Exemption (HDE)

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 Name: NEUROCONTROL CORPORATION VOCARE BLADDER SYSTEM
• Classification Name: bladder system
• Generic Name: bladder system
• Applicant: MDCI; 49 plain st.; north attleboro, MA 02763
• HDE Number: H980005
• Date Received: 08/03/1998
• Decision Date: 12/28/1998
• Product Code: PAT
• Docket Number: 99M-0150
• Advisory Committee: Gastroenterology
• Supplement Type: hde original
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for the vocare(r) bladder system. This device is indicated for the treatment of patients who have clinically complete spinal cord lesions (asia classification) with intact parasympathetic innervation of the bladder and are skeletally mature and neurologically stable, to provide urination on demand and to reduce post-void skeletally mature and neurologically stable, to provide urination on demand and to reduce post-void residual volumes of urine.

Approval Order

Approval Order

Summary

Summary of Safety And Probable Benefit

Labeling

Labeling

• Supplements: S001 S002