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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.

FDA Executive Summary (pdf)

Voting Options (pdf)

FDA Questions (pdf)

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.§552). These redacted portions will
appear as white spaces on the screen or on the printed page.

Sponsors Executive Summary (pdf)

Summary of Safety and Effectiveness Part 1 (pdf)

Draft Labeling: (pdf)

Watchman Instructions for Use (pdf)

Watchman Protect Pivotal Clinical Report 900 Year Results (pdf)

Watchman Left Atrial Appendage System AF Registry Preclinical
Report (pdf)

Watchman Protect AF Pivotal Clinical Report (pdf)

Continued Access Report Protect Post Approval Study (pdf)

Protect AF Long Term Post Approval Study (pdf)

Page last updated April 23, 2009 kkhorizonal rule
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