Product Classification

• Device: implanted diaphragmatic/phrenic nerve stimulator
• Regulation Description: Implanted diaphragmatic/phrenic nerve stimulator.
• Definition: Call for pmas to be filed by 7/7/86 per 51 fr 12101 on 4/8/86.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: GZE
• Submission Type: PMA
• Regulation Number: 882.5830
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 14708-3 2008-11-15 Implants for Surgery - Active implantable medical devices Part 3: Implantable neurostimulators
• AAMI/ANSI/ISO 14708-3 2008-01-01 Implants for surgery - Active implantable medical devices Part 3: Implantable neurostimulators

Third Party Review

Not Third Party Eligible