Product Classification

• Device: pulmonary valve prosthesis percutaneously delivered
• Definition: These devices are intended to replace a patient's pulmonary heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.
• Review Panel: Cardiovascular
• Product Code: NPV
• Premarket Review: Circulatory Support, Structural and Vascular Devices (DHT2B); Circulatory Support, Structural and Vascular Devices (DHT2B)
• Submission Type: PMA
• Device Class: HDE
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Eligible
• Implanted Device?: Yes
• Life-Sustain/Support Device?: Yes

Recognized Consensus Standards

• 3-173 ISO 5840-3 Second edition 2021-01
  Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques
• 3-174 ISO 5840-1 Second edition 2021-01
  Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements

Third Party Review

Not Third Party Eligible