← FDA Medical Device Classifications

Bladder System

PAT · f · Unknown

Classification

FDA Product Code
PAT
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 bladder and are skeletally mature and neurologically stable, to provide urination on demand and to reduce post-void residual volumes of urine.

Market data

Cleared 510(k) submissions
0
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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