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
• Submission Type: PMA
• Regulation Number: 876.5270
• 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

Guidance Document

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

Third Party Review

Not Third Party Eligible