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Drugs and Health Products
Phase 1: Medical Devices
Help on accessing alternative formats, such as Portable Document Format (PDF), Microsoft Word and PowerPoint (PPT) files, can be obtained in the alternate format help section.
All Federal Acts and associated Regulations are available on the 
Justice Canada website.
How to find the Medical Devices Regulations:
- From the introductory paragraph, click on the Justice Canada link
- From the pull-down menu of the Basic Search, click on Consolidated Regulations
- Type Medical Devices Regulations in the In title field and hit OK
A
AB5000 CIRCULATORY SUPPORT SYSTEM
- Notice of Decision [2005-12-06]
- Summary Basis of Decision [2006-01-10]
- Operator's Manual (PDF Version - 1.65 M) [2005-10-11]
- Operator's Manual - AB5000 VENTRICLE (PDF Version - 1.18 M) [2005-10-11]
C
CARDIOWEST C70 TEMPORARY TOTAL ARTIFICIAL HEART
- Notice of Decision [2005-11-30]
- Summary Basis of Decision [2006-01-30]
- Operator's Manual - CIRCULATORY SUPPORT SYSTEM (PDF Version - 1.05 M) [2005-10-27]
- Operator's Manual (PDF Version - 831 K) [2005-10-27]
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]
E
ELANA SURGICAL KIT
- Notice of Decision [2007-12-10]
- Summary Basis of Decision [2008-04-16]
- Operator's Manual (PDF Version - 1.7 K) [2007-11-15]
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]
- Operator's Manual (PDF Version - 359 K) [2006-10-20]
- Package Insert - Augmentation (PDF Version - 640 K) [2006-10-20]
- Package Insert - Reconstruction (PDF Version - 507 K) [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]
- Operator's Manual (PDF Version - 357 K) [2006-10-20]
- Package Insert - Augmentation (PDF Version - 714 K) [2006-10-20]
- Package Insert - Reconstruction (PDF Version - 441 K) [2006-10-20]
Visit the Expert Advisory Panel on Breast Implants
M
MENTOR
MENTOR MEMORYGEL CPG GEL IMPLANTS COHESIVE III
2009
- Summary Basis of Decision [2009-09-18]
2008
- Summary Basis of Decision [2008-08-18]
- Package Insert [2008-08-18]
2006
- Notice of Decision [2006-10-20]
- Summary Basis of Decision [2006-10-20]
- Package Insert (PDF Version - 377 K) [2006-10-20]
- Package Insert - Augmentation (PDF Version - 333 K) [2006-10-20]
- Package Insert - Reconstruction (PDF Version - 466 K) [2006-10-20]
MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS
2009
- Summary Basis of Decision [2009-09-18]
2008
- Summary Basis of Decision [2008-08-18]
- Package Insert - 2008 [2008-08-18]
- Package Insert - 2008 - Texas Facility [2008-08-18]
2006
- Notice of Decision [2006-10-20]
- Summary Basis of Decision [2006-10-20]
- Package Insert [2006-10-20]
- Package Insert (PDF Version - 374 K) [2006-10-20]
- Package Insert - Augmentation (PDF Version - 367 K) [2006-10-20]
- Package Insert - Reconstruction (PDF Version - 492 K) [2006-10-20]
Visit the Expert Advisory Panel on Breast Implants
N
NATRELLE SILICONE-FILLED BREAST IMPLANTS: SMOOTH SHELL with BARRIER LAYER, TEXTURED SHELL with BARRIER LAYER
2009
- Summary Basis of Decision [2009-09-18]
2008
- Summary Basis of Decision [2008-08-18]
- Package Insert - Augmentation [2008-08-18]
- Package Insert - Reconstruction [2008-08-18]
- Operator's Manual [2008-08-18]
Visit the Expert Advisory Panel on Breast Implants
NATRELLE HIGHLY COHESIVE SILICONE-FILLED BREAST IMPLANTS
2009
- Summary Basis of Decision [2009-09-18]
2008
- Summary Basis of Decision [2008-08-18]
- Package Insert - Augmentation [2008-08-18]
- Package Insert - Reconstruction [2008-08-18]
- Operator's Manual [2008-08-18]
Visit the Expert Advisory Panel on Breast Implants
NEUROFORM 2 MICRODELIVERY STENT SYSTEM
- Notice of Decision [2005-05-27]
- Summary Basis of Decision [2005-11-18]
- Package Insert (PDF Version - 508 K) [2005-01-14]
O
ORTHO T. CRUZI ELISA TEST SYSTEM
- Notice of Decision [2007-08-31]
- Summary Basis of Decision [2007-11-14]
- Package Insert (PDF Version - 155 K) [2007-08-03]
P
PROCLEIX SYSTEM
- Notice of Decision [2007-06-29]
- Summary Basis of Decision [2007-09-18]
- Operator's Manual (PDF Version - 547 K) [2007-05-08]
PROCLEIX TIGRIS SYSTEM
- Notice of Decision [2007-06-29]
- Summary Basis of Decision [2007-09-18]
- Operator's Manual (PDF Version - 547 K) [2007-05-08]
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]
- Operator's Manual (PDF Version - 550 K) [2007-05-08]
R
RECOVER PUMP SYSTEM
- Notice of Decision [2007-08-22]
- Summary Basis of Decision [2007-12-20]
- Operator's Manual - RECOVER LD PUMP (PDF Version - 6.42 M) [2007-06-28]
- Operator's Manual - RECOVER LP2.5 PUMP (PDF Version - 4.8 M) [2007-06-28]
- Operator's Manual - RECOVER LP5.0 PUMP (PDF Version - 5.48 M) [2007-06-28]
REPEL-CV
- Notice of Decision [2008-08-27]
- Summary Basis of Decision [2008-12-23]
- Package Insert [2008-07-10]
S
SYPHILIS EIA II
- Notice of Decision [2008-10-03]
- Summary Basis of Decision [2009-02-16]
- Operator's Manual [2008-08-13]
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]
- Operator's Manual for Cardiogenesis Solargen 2100S Laser System [2005-04-08]
- Operator's Manual for Cardiogensis Transmyocardial Revascularization (TMR) 2000 Laser System [2005-04-08]
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]
- Operator's Manual (PDF Version - 221 K) [2007-11-16]
WINGSPAN STENT SYSTEM with GATEWAY PTA BALLOON CATHETER
- Notice of Decision [2005-12-22]
- Summary Basis of Decision [2006-04-06]
- Operator's Manual (PDF Version - 107 K) [2007-11-16]
Z
ZENITH TX2® TAA ENDOVASCULAR GRAFT with INTRODUCTION SYSTEM
- Notice of Decision [2009-04-23]
- Summary Basis of Decision [2009-07-08]
