Product Classification

• Device: stimulator, intracerebral/subcortical, implanted
• Regulation Description: Implanted intracerebral/subcortical stimulator for pain relief.
• Definition: Call for pmas to be filed by 3/1/89 per 53 fr 43621 on 12/1/88.
• Regulation Medical Specialty: Neurology
• Review Panel: Neurology
• Product Code: GYZ
• Submission Type: PMA
• Regulation Number: 882.5840
• 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