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Food and Drug Administration

Circulatory Systems Devices Panel

March 1, 2007

Briefing Infirmation

Medtronic Chrnicle Implantable Hemodynamic Monitoring System

Medtronic

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.

Executive Summary (Vol. 1 Sec.4) (pdf)

Chronicle IHM Summary of Safety & Effectiveness (Vol. 1 Sec.4) (pdf)

Reference Manual (draft) (pdf)

Bibliography (pdf)

FDA

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.

Executive Summary Memorandum (pdf)


Page last updated February 26, 2007 kkhorizonal rule
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