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

Implantable Bladder-Evacuation Electrical Stimulation System

Unknown
FDA source (opens on fda.gov)

ODH is the FDA product code for Implantable Bladder-Evacuation Electrical Stimulation System. FDA's definition for this code reads: "To provide urination on demand and to reduce post-void residual volumes of urine in patients who have clinically complete spinal cord lesions (asia classification) with intact parasympathetic innervations of the bladder and are skeletally mature and neurologically stable". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
ODH
Device name
Implantable Bladder-Evacuation Electrical Stimulation System
FDA definition
To provide urination on demand and to reduce post-void residual volumes of urine in patients who have clinically complete spinal cord lesions (asia classification) with intact parasympathetic innervations of the bladder and are skeletally mature and neurologically stable.
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 ODH.