Stimulator, Intracerebral/subcortical, Implanted

Device Code: 3680

Product Code(s): GYZ

Definition: Call For PMAs To Be Filed By 3/1/89 Per 53 FR 43621 On 12/1/88

Device Classification Information

• Device Type ID: 3680
• Device Name: Stimulator, Intracerebral/subcortical, Implanted
• Regulation Description: Implanted Intracerebral/subcortical Stimulator For Pain Relief.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Neurological And Physical Medicine Devices (DNPMD); Neurostimulation Devices Neurology Branch (NSDN)
• Submission Type: PMA
• CFR Regulation Number: 882.5840 [🔎]
• FDA Device Classification: Class 3 Medical Device
• Product Code: GYZ
• 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: 3680
• Device: Stimulator, Intracerebral/subcortical, Implanted
• Product Code: GYZ
• FDA Device Classification: Class 3 Medical Device
• Regulation Description: Implanted Intracerebral/subcortical Stimulator For Pain Relief.
• CFR Regulation Number: 882.5840 [🔎]

TPLC Last Update: 2019-04-02 20:34:18