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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device implanted tibial electrical urinary continence device
Definition An implanted tibial electrical urinary continence device is an implanted prescription device that receives power from a non-implanted external power source to provide electrical stimulation of the tibial nerve in proximity to the ankle. The device is intended for the treatment of overactive bladder related symptoms of urge urinary incontinence, urinary urgency, urinary frequency and nocturia.
Product CodeQXM
Regulation Number 876.5305
Device Class 2


Premarket Reviews
ManufacturerDecision
BLUEWIND MEDICAL LTD.
  GRANTED 1

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