Product Classification

• Device: stimulator, electrical, implantable, for incontinence
• Regulation Description: Implanted electrical urinary continence device.
• Definition: PMAs to be filed by 12/26/96 (61 FR 50707 (9/27/96))
• Regulation Medical Specialty: Gastroenterology/Urology
• Review Panel: Gastroenterology/Urology
• Product Code: EZW
• Premarket Review: Reproductive, Gynecology and Urology Devices (DHT3B); Reproductive, Gynecology and Urology Devices (DHT3B)
• Submission Type: PMA
• Regulation Number: 876.5270
• Device Class: 3
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: No

Recognized Consensus Standard

• 17-15 ISO 14708-3 Second edition 2017-04
  Implants for surgery - Active implantable medical devices - Part 3: Implantable neurostimulators

Guidance Document

• Clinical Investigations of Devices Indicated for the Treatment of Urinary Incontinence - Guidance for Industry and FDA Staff

Third Party Review

Not Third Party Eligible