PAT — Bladder System Class f
FDA product code PAT covers "Bladder System", a Class f medical device. Submissions are reviewed by the Unknown panel. Devices under this code are implants.
Classification Details
- Product Code
- PAT
- 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 bladder and are skeletally mature and neurologically stable, to provide urination on demand and to reduce post-void residual volumes of urine.