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Ciculatory System Devices Panel

November 30, 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.

2007-4333b2-16- Day 2 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.

2007-4333b2-17- Instructions for use (pdf)
2007-4333b2-18- Operating Manuel (pdf)
2007-4333b2-19 – Patient Handbook (pdf)
2007-4333b2-20- Patient Management Guidelines (pdf)
2007-4333b2-21- Clinical Summary (pdf)
2007-4333b2-22- Post Approval Study (pdf)

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