{
  "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": {
      "skip": 0,
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  "results": [
    {
      "pma_number": "P150035",
      "supplement_number": "S034",
      "applicant": "ABBOTT MEDICAL",
      "street_1": "15900 Valley View Ct.",
      "street_2": "",
      "city": "Sylmar",
      "state": "CA",
      "zip": "91342",
      "zip_ext": "",
      "generic_name": "Leadless pacemaker",
      "trade_name": "Aveir DR Delivery Catheter (LSCD201)",
      "product_code": "PNJ",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "Normal 180 Day Track No User Fee",
      "supplement_reason": "Location Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2025-11-20",
      "decision_date": "2026-02-23",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "approval for a manufacturing site located at Abbott Medical, Interior Lot A Road #2 Km 67.5 Santana Industrial Park Arecibo, Puerto Rico 00612 FEI: 3006705815 for manufacturing, packaging and EO sterilization.",
      "openfda": {
        "registration_number": [
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          "3006705815",
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          "2017865",
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        "device_name": "Leadless Pacemaker",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.3610",
        "device_class": "3"
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}