Advisory Committees
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Briefing Materials (April 23, 2009: Circulatory Devices Panel Meeting)
Food and Drug Administration
Circulatory Devices Panel Meeting
April 23, 2009
BRIEFING INFORMATION
FDA Disclaimer
The statements contained in this document(s) are those of the product 's sponsor, not FDA and FDA does not necessarily agree with the sponsor's statements. FDA has not made a final determination about the safety or effectiveness of the product described in this document.
Sponsor Disclaimer
Portions of this document have been determined to be exempt from disclosure under the
Freedom of Information Act (the FOIA) (5 U.S.C.ยง552). These redacted portions will
appear as white spaces on the screen or on the printed page.
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Related Briefing Documents
FDA Executive Summary (April 23, 2009: Circulatory Devices Panel) (PDF - 2.7MB)Voting Options (April 23, 2009: Circulatory Devices Panel Meeting) (PDF - 54KB)FDA Questions (April 23, 2009: Circulatory Devices Panel Meeting) (PDF - 21KB)Sponsors Executive Summary (April 23, 2009: Circulatory Devices Panel Meeting) (PDF - 4.7MB)Summary of Safety and Effectiveness Part 1 (April 23, 2009: Circulatory Devices Panel Meeting) (PDF - 1.4MB)Draft Labeling (April 23, 2009: Circulatory Devices Panel Meeting) (PDF - 302KB)Watchman Instructions for Use (April 23, 2009: Circulatory Devices Panel Meeting) (PDF - 894KB)Watchman Protect Pivotal Clinical Report 900 Year Results (April 23, 2009: Circulatory Devices Panel Meeting) (PDF - 2.7MB)Watchman Left Atrial Appendage System AF Registry Preclinical (April 23, 2009: Circulatory Devices Panel Meeting) (PDF - 383KB)Watchman Protect AF Pivotal Clinical Report (April 23, 2009: Circulatory Devices Panel Meeting) (PDF - 5.7MB)Continued Access Report Protect Post Approval Study (April 23, 2009: Circulatory Devices Panel Meeting) (PDF - 138KB)Protect AF Long Term Post Approval Study (April 23, 2009: Circulatory Devices Panel Meeting) (PDF - 105KB)
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