Recently Updated Advisory Committee Materials

Recently Updated Advisory Committee Materials

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Contents
-- Recently Updated Advisory Committee Materials
Posted on March 19, 2010
Orthopaedic and Rehabilitation Devices Panel

Krause Meniscus 1976 Final1 (PDF - 5KB)
FDA Executive Summary2 (PDF - 900KB)
European Feasibility Article Final3 (PDF - 5KB)
Regen CS Instructions for Use4 (PDF - 108KB)
Predicate Mesh Comparison Table5 (PDF - 78KB)
Parsons Shoulder Joint 2002 Final6 (PDF - 5KB)
Part 1 - IDE Study CRFs7 (PDF - 449KB)
Acute Study Arm Protocol8 (PDF - 1663KB)
Briggs 2006 Final9 (PDF - 5KB)
Meeting Agenda10 (DOC - 54KB)
Rodeo JBJS Commentary and Perspective11 (PDF - 5KB)
Becker 2006 final12 (PDF - 5KB)
Regen 510K Summary13 (PDF - 70KB)
Depuy Restore Instructions for Use14 (PDF - 659KB)
510(k) SE Flowchart15 (PDF - 32KB)
Redacted Surgical Technique from IDE16 (PDF - 929KB)
JBJS Article17 (PDF - 5KB)
Regen Sponsor Summary18 (PDF - 9609KB)
Redacted 2008 Panel Transcript19 (PDF - 391KB)
Chronic Study Arm20 (PDF - 1667KB)
CMI Feasibility Trial 2 year follow-up Final21 (PDF - 5KB)
Redacted Cleared Package Insert22 (PDF - 192KB)
Regen Executive Summary23 (PDF - 6107KB)
Panel Questions24 (PDF - 27KB)
Fithian Meniscus Properties 1990 Final25 (PDF - 5KB)


-Posted on March 18, 2010

Oncologic Drugs Advisory Committee
- Briefing Information for the March 22, 2010 Meeting of the Oncologic Drugs Advisory Committee26

Vaccines and Related Biological Products Advisory Committee
- 2009 Meeting Materials, Vaccines and Related Biological Products Advisory Committee27

Advisory Committee Calendar
- April 22, 2010: Joint Meeting of the Anesthetic and Life Support Drugs and Drug Safety and Risk Management Advisory Committee Meeting Announcement28


-Posted on March 17, 2010

Advisory Committee Calendar
* April 12, 2010: Blood Products Advisory Committee Meeting Announcement29
* May 6, 2010: Peripheral and Central Nervous System Drugs Advisory Committee Meeting Announcement30


-Posted on March 16, 2010

Orthopaedic and Rehabilitation Devices Panel
Meeting Roster31 (DOC - 34KB)

Circulatory System Devices Panel
Executive Summary32 (PDF - 399KB)
Panel Package Tab 6.05-0533 (PDF - 85KB)
Panel Package Tab 834 (PDF - 17KB)
Panel Package Tab 6.04-0535 (PDF - 48KB)
Panel Package Tab 8.0-0236 (PDF - 1516KB)
Panel Package Tab 6.05-0237 (PDF - 12KB)
US CRT-D US System Guide38 (PDF - 4408KB)
Panel Package Tab 6.05-0439 (PDF - 59KB)
Panel Package Tab 6.04-0440 (PDF - 36KB)
Panel Package Tab 6.04-0241 (PDF - 147KB)
Panel Package Tab 6.04-0142 (PDF - 50KB)
Panel Package Tab 6.01C43 (PDF - 100KB)
Panel Package Tab 6.01B44 (PDF - 759KB)
Panel Package Tab 6.0145 (PDF - 1023KB)
Panel Package Tab 546 (PDF - 408KB)
Panel Package Tab 647 (PDF - 9KB)
Agenda 3/19/1048 (PDF - 13KB)
Agenda for 3/19/1049 (PDF - 13KB)
Roster for 3/18/1050 (DOC - 43KB)

open here to see each report:
http://www.fda.gov/AdvisoryCommittees/WhatsNew/default.htm