Product Classification

• Device: shunt, portosystemic, endoprosthesis
• Review Panel: Cardiovascular
• Product Code: MIR
• Premarket Review: Office of Cardiovascular Devices (OHT2); Circulatory Support, Structural and Vascular Devices (DHT2B)
• Submission Type: PMA
• 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

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