Electrical Stimulation Bladder System

PAZ · f · Unknown

Classification

FDA Product Code: PAZ
Device class: f
Regulation: —
Review panel: GU
Medical specialty: Unknown
Submission type: 6
GMP exempt: N
Life sustaining: N
Implant: Y
Third-party review: N

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.

Market data

Cleared 510(k) submissions: 0
Registered establishments: 0

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown