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Summary Basis of Decision (SBD) Documents: Medical Devices
The SBD documents explain why Health Canada authorized certain medical devices for sale in Canada. The documents include regulatory, safety, effectiveness and quality (manufacturing) considerations.
SBDs are published for a subset of Class IV medical device applications that were authorized after January 1, 2005. Health Canada will draft Phase II SBDs for all eligible medical devices licensed as of September 1, 2012. Eligible products authorized before September 1, 2012, but on or after January 1, 2005, will have SBDs in the Phase I format.
The SBDs are organized alphabetically by product name. Use the following index, or see the list of SBDs below.
Reader's Guide
For an explanation of the information available in each section of a Phase I SBD, consult the Phase I Reader's Guide.
- Phase I Reader's Guide to the SBD - Medical Devices [2005-06-29]
For an explanation of the information available in each section of a Phase II SBD, consult the Phase II Reader's Guide.
- Phase II Reader's Guide to the SBD - Medical Devices [2012-06-29]
Other Resources
For up to date information on a particular product, readers should refer to the Medical Devices Active Licence Listing.
For information related to Warnings, Recalls and Alerts, go to the MedEffect Canada web page.
Readers should refer to the 
Food and Drugs Act and/or the Medical Devices Regulations for more information about the regulation of medical devices.
Readers may also wish to consult the Health Canada website for other policies and guidance documents related to medical devices and medical device applications. In particular, readers may wish to refer to the Management of Applications for Medical Device Licences and Investigational Testing Authorizations Policy.
Summary Basis of Decision Documents: Medical Devices
A
AB5000 CIRCULATORY SUPPORT SYSTEM
- Notice of Decision [2005-12-06]
- Summary Basis of Decision [2006-01-10]
C
CARDIOWEST C70 TEMPORARY TOTAL ARTIFICIAL HEART
- Notice of Decision [2005-11-30]
- Summary Basis of Decision [2006-01-30]
COBAS® AMPLISCREEN HBV TEST
- Notice of Decision [2009-10-19]
- Summary Basis of Decision [2010-02-16]
cobas TaqScreen MPX Test
- Notice of Decision [2009-11-09]
- Summary Basis of Decision [2010-03-04]
MEDTRONIC COREVALVE SYSTEM
- Summary Basis of Decision [2013-01-13]
E
ELANA SURGICAL KIT
- Notice of Decision [2007-12-10]
- Summary Basis of Decision [2008-04-16]
EXCOR® SYSTEM
- Notice of Decision [2009-03-07]
- Summary Basis of Decision [2009-05-06]
H
HEARTMATE II® LEFT VENTRICULAR ASSIST SYSTEM
- Notice of Decision [2009-07-16]
- Summary Basis of Decision [2009-09-16]
I
INAMED
STYLE 410 SILICONE-FILLED BREAST IMPLANT
- Notice of Decision [2006-10-20]
- Summary Basis of Decision [2006-10-20]
SMOOTH SHELL with BARRIER LAYER, TEXTURED SHELL with BARRIER LAYER
- Notice of Decision [2006-10-20]
- Summary Basis of Decision [2006-10-20]
M
MEDTRONIC COREVALVE SYSTEM
- Notice of Decision [2012-10-09]
- Summary Basis of Decision [2013-01-13]
MENTOR
MENTOR MEMORYGEL CPG GEL IMPLANTS COHESIVE III
2012
- Summary Basis of Decision [2012-08-09]
2011
- Summary Basis of Decision [2011-09-27]
2010
- Summary Basis of Decision [2010-09-23]
2009
- Summary Basis of Decision [2009-09-18]
2008
- Summary Basis of Decision [2008-08-18]
2006
- Notice of Decision [2006-10-20]
- Summary Basis of Decision [2006-10-20]
MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
2012
- Summary Basis of Decision [2012-08-09]
2011
- Summary Basis of Decision [2011-09-27]
2010
- Summary Basis of Decision [2010-09-23]
2009
- Summary Basis of Decision [2009-09-18]
2008
- Summary Basis of Decision [2008-08-18]
2006
- Notice of Decision [2006-10-20]
- Summary Basis of Decision [2006-10-20]
N
NATRELLE SILICONE-FILLED BREAST IMPLANTS: SMOOTH SHELL with BARRIER LAYER, TEXTURED SHELL with BARRIER LAYER
2012
- Summary Basis of Decision [2012-09-25]
2011
- Summary Basis of Decision [2011-11-10]
2010
- Summary Basis of Decision [2010-08-25]
2009
- Summary Basis of Decision [2009-09-18]
2008
- Summary Basis of Decision [2008-08-18]
NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS
2012
- Summary Basis of Decision [2012-09-25]
2011
- Summary Basis of Decision [2011-11-10]
2010
- Summary Basis of Decision [2010-08-26]
2009
NEUROFORM 2 MICRODELIVERY STENT SYSTEM
- Notice of Decision [2005-05-27]
- Summary Basis of Decision [2005-11-18]
O
ORTHO T. CRUZI ELISA TEST SYSTEM
- Notice of Decision [2007-08-31]
- Summary Basis of Decision [2007-11-14]
P
PIPELINE EMBOLIZATION DEVICE
- Notice of Decision [2010-07-07]
- Summary Basis of Decision [2010-09-10]
PROCLEIX SYSTEM
- Notice of Decision [2007-06-29]
- Summary Basis of Decision [2007-09-18]
PROCLEIX TIGRIS SYSTEM
- Notice of Decision [2007-06-29]
- Summary Basis of Decision [2007-09-18]
PROCLEIX ULTRIO ASSAY (DONOR SCREENING)
- Notice of Decision [2008-07-24]
- Summary Basis of Decision [2009-02-18]
PROCLEIX WNV ASSAY
- Notice of Decision [2007-06-29]
- Summary Basis of Decision [2007-09-18]
R
RECOVER PUMP SYSTEM
- Notice of Decision [2007-08-22]
- Summary Basis of Decision [2007-12-20]
REPEL-CV
- Notice of Decision [2008-08-27]
- Summary Basis of Decision [2008-12-23]
S
EDWARDS SAPIEN TRANSCATHETER HEART VALVE
- Notice of Decision [2011-08-09]
- Summary Basis of Decision [2012-01-03]
SYMPLICITY RENAL DENERVATION SYSTEM
- Notice of Decision [2012-04-19]
- Summary Basis of Decision [2012-07-25]
SYPHILIS EIA II
- Notice of Decision [2008-10-03]
- Summary Basis of Decision [2009-02-16]
T
TAG THORACIC ENDOPROSTHESIS
- Notice of Decision [2008-12-09]
- Summary Basis of Decision [2009-02-18]
TMR (TRANSMYOCARDIAL REVASCULARIZATION) LASERS
- Notice of Decision [2005-05-27]
- Summary Basis of Decision [2005-11-18]
V
VALIANT® THORACIC STENT GRAFT with XCELERANT® DELIVERY SYSTEM
- Notice of Decision [2008-08-22]
- Summary Basis of Decision [2009-03-04]
W
WEST NILE VIRUS TEST KIT - DONOR SCREENING
- Notice of Decision [2008-01-10]
- Summary Basis of Decision [2008-04-16]
WINGSPAN STENT SYSTEM with GATEWAY PTA BALLOON CATHETER
- Notice of Decision [2005-12-22]
- Summary Basis of Decision [2006-04-06]
Z
ZENITH TX2® TAA ENDOVASCULAR GRAFT with INTRODUCTION SYSTEM
- Notice of Decision [2009-04-23]
- Summary Basis of Decision [2009-07-08]
