510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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PAZHumanitarian device exemption

Electrical Stimulation Bladder System

Unknown
FDA source (opens on fda.gov)

PAZ is the FDA product code for Electrical Stimulation Bladder System. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
PAZ
Device name
Electrical Stimulation Bladder System
FDA 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.
Device class
Humanitarian device exemption
Review panel
Unknown
Submission type
FDA code 6
Implant
Yes
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code PAZ.