Product Classification

• Device: replacement heart-valve
• Regulation Description: Replacement heart valve.
• Definition: Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))
• Regulation Medical Specialty: Cardiovascular
• Review Panel: Cardiovascular
• Product Code: DYE
• Premarket Review: Office of Cardiovascular Devices (OHT2); Circulatory Support, Structural and Vascular Devices (DHT2B)
• Submission Type: PMA
• Regulation Number: 870.3925
• 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 Standards

• 3-174 ISO 5840-1 Second edition 2021-01
  Cardiovascular implants - Cardiac valve prostheses - Part 1: General requirements
• 3-175 ISO 5840-2 Second edition 2021-01
  Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes
• 3-190 ISO PAS 7020 First edition 2023-05
  Sizing parameters of surgical valve prostheses: Requirements regarding the application of ISO 5840-2

Third Party Review

Not Third Party Eligible