Advisory Committees
-
Briefing Materials (March 18, 2009: Circulatory System Devices Panel Meeting)
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 detemlination about the safety or effectiveness of the product described in this
document.
Sponsor Disclaimer
Portions of this document have been determined to be exempt from disclosure under the
Freedom of lnfoffilation Act (the FOIA) (5 U.S.c. ยง552). These redacted portions will
appear as white spaces on the screen or on the printed page.
-
Related Briefing Documents
FDA Executive Summary (March 18, 2009: Circulatory System Devices Panel Meeting) (PDF - 526KB)Voting Options (March 18, 2009: Circulatory System Devices Panel Meeting) (PDF - 45KB)Questions (March 18, 2009: Circulatory System Devices Panel Meeting) (PDF - 23KB)Sponsor Executive Summary (March 18, 2009: Circulatory System Devices Panel Meeting) (PDF - 4.4MB)Proposed Summary of Safety and Effectiveness (March 18, 2009: Circulatory System Devices Panel Meeting) (PDF - 1.9MB)Downstream AO System Device Description (March 18, 2009: Circulatory System Devices Panel Meeting) (PDF - 1.8MB)AMIHOT II Clinical Summary (March 18, 2009: Circulatory System Devices Panel Meeting) (PDF - 21MB)Proposed SSO Therapy Post Approval Study (March 18, 2009: Circulatory System Devices Panel Meeting) (PDF - 2.9MB)Draft Labeling Quick Set Up (March 18, 2009: Circulatory System Devices Panel Meeting) (PDF - 429KB)Bibliography (March 18, 2009: Circulatory System Devices Panel Meeting) (PDF - 636KB)
-
-
-
