Implanted Diaphragmatic/phrenic Nerve Stimulator

Device Code: 220

Product Code(s): GZE

Definition: Call For Pmas To Be Filed By 7/7/86 Per 51 Fr 12101 On 4/8/86

Device Classification Information

• Device Type ID: 220
• Device Name: Implanted Diaphragmatic/phrenic Nerve Stimulator
• Regulation Description: Implanted Diaphragmatic/phrenic Nerve Stimulator.
• Regulation Medical Specialty: Neurology
• Review Panel: Anesthesiology
• Premarket Review: Office Of Device Evaluation (ODE); Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID); Respiratory Devices Branch (RPDB)
• Submission Type: PMA
• CFR Regulation Number: 882.5830 [🔎]
• FDA Device Classification: Class 3 Medical Device
• Product Code: GZE
• 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: 220
• Device: Implanted Diaphragmatic/phrenic Nerve Stimulator
• Product Code: GZE
• FDA Device Classification: Class 3 Medical Device
• Regulation Description: Implanted Diaphragmatic/phrenic Nerve Stimulator.
• CFR Regulation Number: 882.5830 [🔎]

TPLC Last Update: 2019-04-02 19:30:51