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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

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22 rows where docket_id = "FDA-2011-N-0650" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;