Stimulator, Spinal-cord, Implanted, For Bladder Evacuation

Device Code: 2163

Product Code(s): GZD

Definition: Call For PMAs To Be Filed By 12/26/96 Per 61 FR 50708 On 9/27/96

Device Classification Information

• Device Type ID: 2163
• Device Name: Stimulator, Spinal-cord, Implanted, For Bladder Evacuation
• Regulation Description: Implanted Spinal Cord Stimulator For Bladder Evacuation.
• Regulation Medical Specialty: Neurology
• Review Panel: Gastroenterology/Urology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Neurological And Physical Medicine Devices (DNPMD); Physical Medicine And Rehabilitation Devices Branch (PMDB)
• Submission Type: PMA
• CFR Regulation Number: 882.5850 [🔎]
• FDA Device Classification: Class 3 Medical Device
• Product Code: GZD
• GMP Exempt: No
• Summary MR: Eligible
• Implanted Device: Yes
• Life Support Device: No
• Third Party Review: Not Third Party Eligible

Recognized Standards

• 17-15 ISO 14708-3 Second Edition 2017-04
  Implants For Surgery - Active Implantable Medical Devices - Part 3: Implantable Neurostimulators

Total Product Life Cycle

• Device Type ID: 2163
• Device: Stimulator, Spinal-cord, Implanted, For Bladder Evacuation
• Product Code: GZD
• FDA Device Classification: Class 3 Medical Device
• Regulation Description: Implanted Spinal Cord Stimulator For Bladder Evacuation.
• CFR Regulation Number: 882.5850 [🔎]

TPLC Last Update: 2019-04-02 20:06:58