{
  "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,
      "limit": 1,
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  "results": [
    {
      "pma_number": "P010015",
      "supplement_number": "",
      "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": "Implantable pulse generator, pacemaker (non-CRT)",
      "trade_name": "MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM",
      "product_code": "LWP",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "",
      "supplement_reason": "",
      "expedited_review_flag": "Y",
      "date_received": "2001-03-02",
      "decision_date": "2001-08-28",
      "docket_number": "01M-0373",
      "fed_reg_notice_date": "2001-08-30",
      "decision_code": "APPR",
      "ao_statement": "APPROVAL FOR THE MEDTRONIC INSYNC BIVENTRICULAR PACING SYSTEM INCLUDING THE MODEL 8040 INSYNC PULSE GENERATOR, THE MODEL 9980 PROGRAMMER SOFTWARE, AND THE ATTAIN LV MODEL 2187 AND ATTAIN CS MODEL 2188 LEADS.  THE PULSE GENERATOR AND LEADS ARE INDICATED AS FOLLOWS:  1) THE INSYNC MODEL 8040 PULSE GENERATOR IS INDICATED FOR THE REDUCTION OF THE SYMPTOMS OF MODERATE TO SECERE HEART FAILURE (NYHA FUNCTIONAL CLASS III OR IV) IN THOSE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL, MEDICAL THERAPY, AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <= 35% AND A QRS DURATION = 130 MS.  2) THE ATTAIN LV MODEL 2187 LEAD HAS APPLICATION AS PART OF A MEDTRONIC BIVENTRICULAR PACING SYSTEM.  3) THE ATTAIN CS MODEL 2188 LEAD HAS APPLICATION WHERE PERMANENT ATRIAL, OR FUAL-CHAMBER PACING SYSTEMS ARE INDICATED, OR AS PART OF A MEDTRONIC BIVENTRICULAR PACING SYSTEM.",
      "openfda": {
        "device_name": "Implantable Pulse Generator, Pacemaker (Non-Crt)",
        "medical_specialty_description": "Unknown",
        "regulation_number": "",
        "device_class": "3",
        "registration_number": [
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