id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
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,,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,,,2014-09-15T18:12:20Z,,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,,,2014-09-15T18:13:35Z,,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,,,2014-09-15T18:11:41Z,,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,,,2014-09-15T18:12:33Z,,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,,,2014-09-15T18:12:46Z,,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,,,2014-09-15T18:12:54Z,,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,,,2014-09-15T18:11:54Z,,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,,,2014-09-15T18:13:14Z,,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,,,2014-09-15T18:13:08Z,,0,0,0900006481872310
FDA-2011-N-0650-0006,FDA,FDA-2011-N-0650,"Cardiovascular Devices; Reclassification of External Pacemaker
Pulse 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,,,2014-09-15T18:13:28Z,,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,,,2014-09-15T18:13:41Z,,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,,,2014-09-15T18:12:27Z,,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,,,2014-09-15T18:12:04Z,,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,,,2014-09-15T18:12:12Z,,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,,,2014-09-15T18:13:22Z,,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,,,2014-09-15T18:13:00Z,,0,0,090000648187230f
FDA-2011-N-0650-0024,FDA,FDA-2011-N-0650,"Reference 17 - Voigtländer T., B, Nowak, P. Bärenfänger, 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,,,2014-09-15T18:13:49Z,,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,,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,,,2014-09-15T18:11:48Z,,0,0,09000064818722fe
FDA-2011-N-0650-0001,FDA,FDA-2011-N-0650,Cardiovascular Devices: Reclassification of External Pacemaker Pulse Generator Devices,Proposed Rule,Notice of Proposed Rulemaking (NPRM),2011-10-17T04:00:00Z,2011,10,2011-10-17T04:00:00Z,2012-01-18T04:59:59Z,2011-10-17T13:19:24Z,2011-26625,0,0,0900006480f54001