{
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    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-12",
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      "pma_number": "P130021",
      "supplement_number": "S058",
      "applicant": "Medtronic, Inc.",
      "street_1": "710 Medtronic Pkwy.",
      "street_2": "",
      "city": "Miinneapolis",
      "state": "MN",
      "zip": "55432",
      "zip_ext": "",
      "generic_name": "Aortic valve, prosthesis, percutaneously delivered",
      "trade_name": "Medtronic CoreValve™ Evolut™ R System and Medtronic CoreValve™ Evolut™ Pro System",
      "product_code": "NPT",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Panel Track",
      "supplement_reason": "Labeling Change - Indications/instructions/shelf life/tradename",
      "expedited_review_flag": "N",
      "date_received": "2019-03-15",
      "decision_date": "2019-08-16",
      "docket_number": "19M-3844",
      "fed_reg_notice_date": "2019-08-16",
      "decision_code": "APPR",
      "ao_statement": "Approval for the Medtronic CoreValve Evolut R System and Medtronic CoreValve Evolut PRO System for expanding the indication to include patients at low risk for surgical aortic valve replacement. The devices are indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis who are judged by a heart team, including a cardiac surgeon, to be appropriate for the transcatheter heart valve replacement therapy.",
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