PAZ — Electrical Stimulation Bladder System Class f
FDA product code PAZ covers "Electrical Stimulation Bladder System", a Class f medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- PAZ
- Device Class
- Class f
- Regulation Number
- Submission Type
- Review Panel
- GU
- Medical Specialty
- Unknown
- Implant
- Yes
Definition
for the treatment of patients who have complete spinal cord lesions (ASIA Classification) with intact parasympathetic innervation of the bowel and are skeletally mature and neurologically stable, to provide bowel evacuation.