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Place: Holland Cross, Tower B, Paradigm Room
Date and Time: December 10, 2010 8:00 to 4:00
Participants: SAC MDUCS members, Health Canada
Science Advisor: Hripsime Shahbazian
Scientific and Regulatory Officer: Larissa Lefebvre
Chairperson: Dr. Ducas
07:30-08:00
Refreshments
08:00-08:15
Opening remarks
Review of the Agenda, Declarations of affiliations and interests
08:15-08:45
Summary of how the information from previous meetings is being used
Kevin Day (Medical Device Bureau)
08:45-10:00
Question 1: Electrophysiology - Introduction of sensors into cardiac resynchronization Therapy (CRT) devices for the treatment and optimization of Heart Failure treatment
Dr. Mitchell
10:30-10:15
Break
10:15-11:15
Question 2: Drug eluting balloons (DEB)
Guest speaker - Dr. Olivier Bertrand
11:15-12:00
Question 3: Overview of the Special Access Program (SAP)
Kevin Day
12:00-1:00
Lunch
1:00-2:00
Question 4: "Sutureless" aortic valves
Dr. Menkis
2:00-3:00
Question 5: Human factor issues related to cardiovascular medical devices
Dr. Ducas
3:00-3:45
Question 6: Overview of recall procedures
Marketed Health Products Directorate, Health Products and Food Branch Inspectorate and Medical Devices Bureau
3:45-4:00
Next steps, Closing Remarks and Adjournment of Meeting