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U.S. Department of Health and Human Services

Product Classification
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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 CodeDYE
Submission Type PMA
Regulation Number 870.3925
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Recognized Consensus Standards
Guidance Document
  • Draft Guidance for Industry and FDA Staff: Heart Valves - Investigational Device Exemption (IDE) and Premarket Approval (PMA) Applications [http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm193096.htm] 
Third Party Review Not Third Party Eligible
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