Stimulator, Tibial, Electrical, Implantable, For Urinary Incontinence
QPT · Class III — High Risk (PMA approval required, life-sustaining) · Unknown
Classification
FDA Product Code
QPT
Device class
Class III — High Risk (PMA approval required, life-sustaining)
Regulation
—
Review panel
GU
Medical specialty
Unknown
Submission type
2
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
Definition
Implanted electrical stimulator, including implanted power source, for treatment of overactive bladder or symptoms of overactive bladder through electrical stimulation of the tibial nerve.