Product Classification

• Device: stimulator, neuromuscular, implanted
• Regulation Description: Implanted neuromuscular stimulator.
• Definition: Call for pmas to be filed by 7/13/99 per 64 fr 18329 on 4/14/99.
• Regulation Medical Specialty: Neurology
• Review Panel: Physical Medicine
• Product Code: GZC
• Submission Type: PMA
• Regulation Number: 882.5860
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

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

Third Party Review

Not Third Party Eligible