{
  "companyId": "69235",
  "slug": "pacesetter-systems-69235",
  "name": "Pacesetter Systems",
  "clearances": {
    "total": 96,
    "last12Months": 0,
    "first": "1976-11-11",
    "latest": "1991-08-28"
  },
  "medianReviewDays": 60,
  "productCodeCount": 12,
  "recalls": {
    "total": 0,
    "openLast12Months": 0,
    "recent": []
  },
  "registration": {
    "sites": 0,
    "countries": []
  },
  "productCodes": [
    {
      "code": "DTB",
      "deviceName": "Permanent Pacemaker Electrode",
      "clearances": 33,
      "latest": "1991-08-28",
      "medianReviewDays": 49
    },
    {
      "code": "DXY",
      "deviceName": "Implantable Pacemaker Pulse-Generator",
      "clearances": 28,
      "latest": "1989-03-28",
      "medianReviewDays": 78
    },
    {
      "code": "DTD",
      "deviceName": "Pacemaker Lead Adaptor",
      "clearances": 20,
      "latest": "1990-06-25",
      "medianReviewDays": 28
    },
    {
      "code": "FRN",
      "deviceName": "Pump, Infusion",
      "clearances": 7,
      "latest": "1986-06-09",
      "medianReviewDays": 53
    },
    {
      "code": "DSY",
      "deviceName": "Prosthesis, Vascular Graft, Of 6mm And Greater Diameter",
      "clearances": 1,
      "latest": "1983-12-21",
      "medianReviewDays": 352
    },
    {
      "code": "DTG",
      "deviceName": "Magnet, Test, Pacemaker",
      "clearances": 1,
      "latest": "1981-12-02",
      "medianReviewDays": 26
    },
    {
      "code": "DXH",
      "deviceName": "Transmitters And Receivers, Electrocardiograph, Telephone",
      "clearances": 1,
      "latest": "1983-08-12",
      "medianReviewDays": 99
    },
    {
      "code": "DYB",
      "deviceName": "Introducer, Catheter",
      "clearances": 1,
      "latest": "1987-06-05",
      "medianReviewDays": 72
    },
    {
      "code": "FPA",
      "deviceName": "Set, Administration, Intravascular",
      "clearances": 1,
      "latest": "1983-09-12",
      "medianReviewDays": 130
    },
    {
      "code": "KNG",
      "deviceName": "Monitor, Ultrasonic, Fetal",
      "clearances": 1,
      "latest": "1983-01-08",
      "medianReviewDays": 68
    },
    {
      "code": "KRE",
      "deviceName": "Analyzer, Pacemaker Generator Function, Indirect",
      "clearances": 1,
      "latest": "1983-12-16",
      "medianReviewDays": 60
    },
    {
      "code": "KRG",
      "deviceName": "Programmer, Pacemaker",
      "clearances": 1,
      "latest": "1986-04-23",
      "medianReviewDays": 69
    }
  ],
  "productCodesShown": 12,
  "productCodesTotal": "12",
  "recentClearances": [
    {
      "kNumber": "K910924",
      "deviceName": "ENDOCARDIAL LEADS-MOD. TO THE POLYVINYLPYRROLIDONE",
      "productCode": "DTB",
      "decisionDate": "1991-08-28",
      "reviewDays": 176
    },
    {
      "kNumber": "K902147",
      "deviceName": "ENDOCARDIAL SCREW-IN LEAD MODEL 1028T",
      "productCode": "DTB",
      "decisionDate": "1990-07-17",
      "reviewDays": 63
    },
    {
      "kNumber": "K900512",
      "deviceName": "SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS",
      "productCode": "DTD",
      "decisionDate": "1990-06-25",
      "reviewDays": 143
    },
    {
      "kNumber": "K900550",
      "deviceName": "FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T",
      "productCode": "DTB",
      "decisionDate": "1990-04-20",
      "reviewDays": 73
    },
    {
      "kNumber": "K895447",
      "deviceName": "ENDOCARDIAL SCREW-IN LEAD MODEL 1020T",
      "productCode": "DTB",
      "decisionDate": "1989-12-20",
      "reviewDays": 103
    },
    {
      "kNumber": "K891905",
      "deviceName": "CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE",
      "productCode": "DTB",
      "decisionDate": "1989-06-05",
      "reviewDays": 70
    },
    {
      "kNumber": "K885267",
      "deviceName": "VS-1 MODEL NUMBER 251K PULSE GENERATOR",
      "productCode": "DXY",
      "decisionDate": "1989-03-28",
      "reviewDays": 96
    },
    {
      "kNumber": "K890547",
      "deviceName": "SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS",
      "productCode": "DTB",
      "decisionDate": "1989-03-22",
      "reviewDays": 47
    },
    {
      "kNumber": "K884733",
      "deviceName": "AFP MODEL 262T PULSE GENERATOR",
      "productCode": "DXY",
      "decisionDate": "1989-02-10",
      "reviewDays": 92
    },
    {
      "kNumber": "K883087",
      "deviceName": "PROLOG MP 658M PULSE GENERATOR",
      "productCode": "DXY",
      "decisionDate": "1988-09-14",
      "reviewDays": 55
    }
  ],
  "nameVariants": {
    "total": "1",
    "shown": [
      {
        "name": "Pacesetter Systems",
        "dataset": "device/510k",
        "method": "normalised"
      }
    ]
  },
  "sources": {
    "clearances": "https://api.fda.gov/device/510k.json?search=applicant%3A%22Pacesetter%20Systems%22",
    "recalls": "https://api.fda.gov/device/recall.json?search=recalling_firm%3A%22Pacesetter%20Systems%22"
  },
  "provenance": [
    {
      "dataset": "device/510k",
      "loadedAt": "2026-08-10T19:40:09Z",
      "ingestRun": 51
    },
    {
      "dataset": "device/classification",
      "loadedAt": "2026-08-10T06:54:18Z",
      "ingestRun": 2
    },
    {
      "dataset": "device/enforcement",
      "loadedAt": "2026-08-10T19:40:12Z",
      "ingestRun": 53
    },
    {
      "dataset": "device/event",
      "loadedAt": "2026-08-11T13:58:22Z",
      "ingestRun": 74
    },
    {
      "dataset": "device/recall",
      "loadedAt": "2026-08-10T19:40:11Z",
      "ingestRun": 52
    },
    {
      "dataset": "device/registrationlisting",
      "loadedAt": "2026-08-10T07:06:24Z",
      "ingestRun": 10
    }
  ],
  "retrievedAt": "2026-08-11T14:48:53.047Z"
}
