{
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    "terms": "https://open.fda.gov/terms/",
    "license": "https://open.fda.gov/license/",
    "last_updated": "2026-10-05",
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      "applicant": "ABBOTT MEDICAL",
      "street_1": "15900 Valley View Ct.",
      "street_2": "",
      "city": "Sylmar",
      "state": "CA",
      "zip": "91335",
      "zip_ext": "",
      "generic_name": "Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes",
      "trade_name": "UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isoflex Low Voltage 1944/1948, Ten",
      "product_code": "NVN",
      "advisory_committee": "CV",
      "advisory_committee_description": "Cardiovascular",
      "supplement_type": "135 Review Track For 30-Day Notice",
      "supplement_reason": "Process Change - Manufacturer/Sterilizer/Packager/Supplier",
      "expedited_review_flag": "N",
      "date_received": "2026-05-06",
      "decision_date": "2026-06-11",
      "docket_number": "",
      "decision_code": "APPR",
      "ao_statement": "approval for a predetermined change control plan (PCCP) that encompasses a the installation and validation of a semi-automated device packaging line and a cleanroom expansion of current ISO 7 cleanrooms into recently converted ISO 7 cleanrooms at Abbott’s bradycardia lead manufacturing site. The supplement also requested approval for conversion of some ISO 8 cleanrooms into ISO 7 cleanrooms, which will subsequently be expanded as part of the PCCP.",
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        "device_name": "Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes",
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