{
  "meta": {
    "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.",
    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-05",
    "results": {
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  "results": [
    {
      "pma_number": "P150033",
      "supplement_number": "S221",
      "applicant": "Medtronic, Inc.",
      "street_1": "8200 Coral Sea St. N.E",
      "street_2": "Ms Mvs11",
      "city": "Mounds View",
      "state": "MN",
      "zip": "55112",
      "zip_ext": "",
      "generic_name": "Leadless pacemaker",
      "trade_name": "Micra Transcatheter Pacing System (MC1VR01), Micra AV Transcatheter Pacing System (MC1AVR1), Micra VR2 Transcatheter Pac",
      "product_code": "PNJ",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2026-01-13",
      "decision_date": "2026-02-11",
      "docket_number": "",
      "decision_code": "OK30",
      "ao_statement": "an additional, alternative external Process Challenge Device (ePCD) for routine monitoring of the ethylene-oxide-sterilization process and reduction the incubation time of the proposed ePCD from the standard 7 days to 4 days",
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        "regulation_number": "870.3610",
        "device_class": "3"
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}