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Food and Drug Administration

Ciculatory System Devices Panel

November 29, 2007

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.

2007-4333b1-01- FDA- Executive Summary (pdf)

Sponsor: Abbott Vascular, Inc.

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 space on the screen or on the printed page.

Sponsor Executive Summary (pdf)

Table of Contents (Sponsor Panel Pack) (pdf)

XIENCE V. Everolimus-Eluting Coronary Stent System Description (pdf)

XIENCE V EECSS Clinical Experience – Individual Trial Summaries (pdf)

XIENCE V EECSS Proposed Post Approval Study (pdf)

XIENCE V USA Post-Approval Protocol (pdf)

XIENCE V EECSS Summary of Safety and Effectiveness (pdf)
Labeling (pdf)

XIENCE V EECSS Instructions for use (pdf)

References (pdf)

Additional Docucments

2007-4333b1-23- Sponsor (Abbot Vascular) Amendment1_Final 2Y SPIRIT II_SPIRIT III Meta analysis (pdf)

2007-4333b1-24- Sponsor (Abbot Vascular) – Year Complete Analysis – Final (replacement page 6-58) (pdf)

2007-4333b1-25- FDA- Executive Summary – SPIRIT II and III 2-year Completer Analysis (pdf)


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