The meeting will be held on October 2, 2008, from 8:00 a.m. to 5 p.m., and on October 3, 2008, from 8:00 a.m. to 12:00 p.m. at the following location:
Hilton Washington DC North / Gaithersburg
620 Perry Parkway,
Gaithersburg, Maryland, 20877
(301) 977-8900
Online registration is now closed.
7:45 AM | Arrive at Gaithersburg Hilton Registration / Check-in |
8:00 AM | Welcome and Introduction Jonathan Sackner-Bernstein, MD, Associate Center Director for Postmarket Operations, FDA Center for Devices and Radiological Health |
8:30 AM | Topic 1: Clinical Diagnosis of ICD and Pacemaker Lead Problems
|
9:15 AM | Topic 2: Returned Product Analysis
|
10:00 AM | Break |
10:15 AM | Topic 3: Adverse Event Reporting
|
11:00 AM | Topic 4: Post-Approval Studies, Registries and Home Monitoring
|
11:45 AM | Instructions for Breakout Sessions |
12:00 noon | Lunch |
1:20 PM | BREAKOUT SESSIONS Topic #1: Clinical Diagnosis of Pacemaker and ICD Lead Problems Topic #2: Returned Product Analysis Topic #3: Adverse Event Reporting Topic #4: Postapproval Studies, Registries, Home Monitoring |
3:00 PM | Break |
3:15 PM | Resume Breakout Sessions |
5:00 PM | Adjourn from Breakout Sessions |
The workshop organizers may be contacted at:
Megan Moynahan
Network Leader, Cardiac Electrophysiology and Monitoring Network
Office of the Center Director, CDRH
Food and Drug Administration
7520 Standish Place, HFZ-4
Rockville, MD 20855
Phone: (240) 276-8707
Fax: (240) 276-8855
e-mail: megan.moynahan@fda.hhs.gov
Mark Fellman
Scientific Reviewer
Division of Cardiovascular Devices
Office of Device Evaluation, CDRH
Food and Drug Administration
9200 Corporate Boulevard
Rockville, MD 20850
Phone: (240) 276-4060
Fax: (240) 276-4002
e-mail: mark.fellman@fda.hhs.gov
Updated September 26, 2008
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