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Ciculatory System Devices Panel
November 30, 2007
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.
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)