Product Classification

• Device: stimulator, spinal-cord, implanted (pain relief)
• Regulation Description: Implanted spinal cord stimulator for pain relief.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: GZB
• Submission Type: 510(k)
• Regulation Number: 882.5880
• Device Class: 2
• 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