{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and docket_id = \"FDA-2011-N-0650\" sorted by posted_date descending", "rows": [["FDA-2011-N-0650-0026", "FDA", "FDA-2011-N-0650", "Cardiovascular Devices; Reclassification of External Pacemaker Pulse Generator Devices; Reclassification of Pacing System Analyzers", "Rule", "Final Rule", "2016-04-18T04:00:00Z", 2016, 4, "2016-04-18T04:00:00Z", null, "2016-04-18T18:52:03Z", "2016-08898", 0, 0, "0900006481f70626"], ["FDA-2011-N-0650-0012", "FDA", "FDA-2011-N-0650", "Reference 5 - Braun, M. U., T. Rauwolf, M. Bock, et al., \"Percutaneous Lead Implantation Connected to an External Device in Stimulation-Dependent Patients With Systemic Infection--A Prospective and Controlled Study,\"", "Supporting & Related Material", "Background Material", "2014-09-15T04:00:00Z", 2014, 9, null, null, "2014-09-15T18:12:20Z", null, 0, 0, "0900006481872302"], ["FDA-2011-N-0650-0022", "FDA", "FDA-2011-N-0650", "Reference 15 - Pinneri, F., S. Frea, K. Najd, et al., \"Echocardiography-Guided Versus Fluoroscopy-Guided Temporary Pacing in the Emergency Setting: An Observational Study\"", "Supporting & Related Material", "Background Material", "2014-09-15T04:00:00Z", 2014, 9, null, null, "2014-09-15T18:13:35Z", null, 0, 0, "0900006481872314"], ["FDA-2011-N-0650-0007", "FDA", "FDA-2011-N-0650", "List of References", "Supporting & Related Material", "Background Material", "2014-09-15T04:00:00Z", 2014, 9, null, null, "2014-09-15T18:11:41Z", null, 0, 0, "09000064818722fd"], ["FDA-2011-N-0650-0014", "FDA", "FDA-2011-N-0650", "Reference 7 - Dunn, D. L. and J. J. Gregory, \"Noninvasive Temporary Pacing: Experience in a Community Hospital", "Supporting & Related Material", "Background Material", "2014-09-15T04:00:00Z", 2014, 9, null, null, "2014-09-15T18:12:33Z", null, 0, 0, "0900006481872304"], ["FDA-2011-N-0650-0015", "FDA", "FDA-2011-N-0650", "Reference 8 - Eberhardt, F., T. Hanke, M. Heringlake, et al., \"Feasibility of Temporary Biventricular Pacing in Patients With Reduced Left Ventricular Function After Coronary Artery Bypass Grafting", "Supporting & Related Material", "Background Material", "2014-09-15T04:00:00Z", 2014, 9, null, null, "2014-09-15T18:12:46Z", null, 0, 0, "090000648187230d"], ["FDA-2011-N-0650-0016", "FDA", "FDA-2011-N-0650", "Reference 9 - Ferguson, T. B. Jr. and J. L. Cox, \"Temporary External DDD Pacing After Cardiac Operations", "Supporting & Related Material", "Background Material", "2014-09-15T04:00:00Z", 2014, 9, null, null, "2014-09-15T18:12:54Z", null, 0, 0, "090000648187230e"], ["FDA-2011-N-0650-0009", "FDA", "FDA-2011-N-0650", "Reference 2 - The panel transcript and other meeting materials for the September 11, 2013, Circulatory System Devices Panel", "Supporting & Related Material", "Background Material", "2014-09-15T04:00:00Z", 2014, 9, null, null, "2014-09-15T18:11:54Z", null, 0, 0, "09000064818722ff"], ["FDA-2011-N-0650-0019", "FDA", "FDA-2011-N-0650", "Reference 12 - Janousek J., P. Vojtovic, and R. A. Gebauer, \"Use of a Modified, Commercially Available Temporary Pacemaker for R Wave Synchronized Atrial Pacing in Postoperative Junctional Ectopic Tachycardia", "Supporting & Related Material", "Background Material", "2014-09-15T04:00:00Z", 2014, 9, null, null, "2014-09-15T18:13:14Z", null, 0, 0, "0900006481872311"], ["FDA-2011-N-0650-0018", "FDA", "FDA-2011-N-0650", "Reference 11-  Hindman, M. C., G. S. Wagner, M. JaRo, et al., \"The Clinical Significance of Bundle Branch Block Complicating Acute Myocardial Infarction. Indications for Temporary and Permanent Pacemaker Insertion", "Supporting & Related Material", "Background Material", "2014-09-15T04:00:00Z", 2014, 9, null, null, "2014-09-15T18:13:08Z", null, 0, 0, "0900006481872310"], ["FDA-2011-N-0650-0006", "FDA", "FDA-2011-N-0650", "Cardiovascular Devices; Reclassification of External Pacemaker\nPulse Generator Devices; Reclassification of Pacing System Analyzers", "Proposed Rule", "Notice of Proposed Rulemaking (NPRM)", "2014-09-15T04:00:00Z", 2014, 9, "2014-09-15T04:00:00Z", "2014-12-16T04:59:59Z", "2014-12-16T03:01:20Z", "2014-21814", 0, 0, "0900006481871aee"], ["FDA-2011-N-0650-0021", "FDA", "FDA-2011-N-0650", "Reference 14 - Nimetz, A. A., S. J. Shubrooks , A. M. Hutter ,and R. W. DeSanctis, \"The Significance of Bundle Branch Block During Acute Myocardial Infarction", "Supporting & Related Material", "Background Material", "2014-09-15T04:00:00Z", 2014, 9, null, null, "2014-09-15T18:13:28Z", null, 0, 0, "0900006481872313"], ["FDA-2011-N-0650-0023", "FDA", "FDA-2011-N-0650", "Reference 16 - Siddons, H., \"Transvenous Long-Term Pacing With an External Pacemaker. What Are the Risks", "Supporting & Related Material", "Background Material", "2014-09-15T04:00:00Z", 2014, 9, null, null, "2014-09-15T18:13:41Z", null, 0, 0, "0900006481872315"], ["FDA-2011-N-0650-0013", "FDA", "FDA-2011-N-0650", "Reference 6 - Ceresnak, S. R., R. H. Pass, T. J. Starc, et al., \"Predictors for Hemodynamic Improvement With Temporary Pacing After Pediatric Cardiac Surgery\"", "Supporting & Related Material", "Background Material", "2014-09-15T04:00:00Z", 2014, 9, null, null, "2014-09-15T18:12:27Z", null, 0, 0, "0900006481872303"], ["FDA-2011-N-0650-0010", "FDA", "FDA-2011-N-0650", "Reference 3 - Infarction ACC/AHA Guidelines for the Management of Patients With ST-Elevation Myocardial", "Supporting & Related Material", "Background Material", "2014-09-15T04:00:00Z", 2014, 9, null, null, "2014-09-15T18:12:04Z", null, 0, 0, "0900006481872300"], ["FDA-2011-N-0650-0011", "FDA", "FDA-2011-N-0650", "Reference 4 - Beland, M. J., P. S. Hesslein, C. D. Finlay, et al., \"Noninvasive Transcutaneous Cardiac Pacing in Children", "Supporting & Related Material", "Background Material", "2014-09-15T04:00:00Z", 2014, 9, null, null, "2014-09-15T18:12:12Z", null, 0, 0, "0900006481872301"], ["FDA-2011-N-0650-0020", "FDA", "FDA-2011-N-0650", "Reference 13 - Kratz, J. and J. Tyler, \"Clinical Experience with a New DDD External Pacemaker", "Supporting & Related Material", "Background Material", "2014-09-15T04:00:00Z", 2014, 9, null, null, "2014-09-15T18:13:22Z", null, 0, 0, "0900006481872312"], ["FDA-2011-N-0650-0017", "FDA", "FDA-2011-N-0650", "Reference 10 - Halldorsson, A. O., W. T. Vigneswaran, F. J. Podbielski, and D. M. Evans, \"Electrophysiological and Clinical Comparison of Two Temporary Pacing Leads Following Cardiac Surgery", "Supporting & Related Material", "Background Material", "2014-09-15T04:00:00Z", 2014, 9, null, null, "2014-09-15T18:13:00Z", null, 0, 0, "090000648187230f"], ["FDA-2011-N-0650-0024", "FDA", "FDA-2011-N-0650", "Reference 17 - Voigtl\u00e4nder T., B, Nowak, P. B\u00e4renf\u00e4nger, et al., \"Feasibility and Sensing Thresholds of Temporary Single-Lead VDD Pacing in Intensive Care", "Supporting & Related Material", "Background Material", "2014-09-15T04:00:00Z", 2014, 9, null, null, "2014-09-15T18:13:49Z", null, 0, 0, "0900006481872316"], ["FDA-2011-N-0650-0005", "FDA", "FDA-2011-N-0650", "Cardiovascular Devices; Withdrawal of Proposed Rule of Reclassification of External Pacemaker Pulse Generator Devices", "Proposed Rule", "Withdrawal", "2014-09-15T04:00:00Z", 2014, 9, "2014-09-15T04:00:00Z", null, "2014-09-15T14:39:00Z", "2014-21816", 0, 0, "0900006481871b7a"], ["FDA-2011-N-0650-0008", "FDA", "FDA-2011-N-0650", "Reference 1 - Class II Special Controls Draft Guidance Document: External Pacemaker Pulse Generator", "Supporting & Related Material", "Background Material", "2014-09-15T04:00:00Z", 2014, 9, null, null, "2014-09-15T18:11:48Z", null, 0, 0, "09000064818722fe"], ["FDA-2011-N-0650-0001", "FDA", "FDA-2011-N-0650", "Cardiovascular Devices: 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