Approved in 2020: Medical devices

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Medical devices: Approved in 2020

There are different classes of medical devices, ranging from Class I to IV. Class I devices are considered low-risk devices, for example, a tongue depressor. Class IV devices present the greatest potential risk, for example, a pacemaker.

This section outlines the new Class IV medical devices approved for sale in Canada in 2020, and the safety updates issued.

Health categories

The medical devices listed have been divided into categories according to the Global Medical Device Nomenclature system for naming and grouping medical devices.

We have included the indication of each new medical device to give you some additional information. In addition, each new device has a hyperlink to the Decision summary (when available). These documents provide a brief overview of the rationale for our decision to approve the medical device.

The categories are:

  1. Blood fluid and tissue management devices - for example, blood separation systems.
  2. Body tissue manipulation and reparation devices - for example, bone grafts and dermal dressings.
  3. Cardiovascular devices - for example, cardiovascular catheters and pacemakers.
  4. Gastro-urological devices - for example, incontinence control systems.
  5. General hospital devices - for example, infusion pumps.
  6. In vitro diagnostic medical devices - for example, instrument/analyser and viral infection disease in vitro devices.
  7. Neurological devices - for example, neurological stimulation devices.
  8. Plastic surgery and cosmetic devices - for example, breast implants.
  9. Radiological devices – for example, ultrasound imagine systems.
  10. Various - applicable to medical devices generally.

Important definitions

Licence with conditions (identified with 'C' icon)

A medical device licence may be issued with conditions set out by Health Canada. For example, the manufacturer may be required to submit additional information on an on-going basis for the medical device to demonstrate that it continues to meet our regulatory requirements.

Medical device

Medical devices are products that are used for diagnostic and/or therapeutic purposes. Newly approved medical devices provide a broader range of products used to treat, manage, diagnose or prevent a disease or a physical condition.

Novel technology (identified with 'N' icon)

Medical devices with novel technology introduce a new apparatus, appliance, software or material with novel technology never before approved for sale in Canada.

Safety updates

Safety updates are designed to communicate information about potential health risks, so that patients and health care professionals can make informed decisions about their health.

For more information about the types of risk communications that can be found on the Government of Canada's website, go to "Healthy clicks: Medical devices at a glance".

You can report medical device incidents to your medical professional, to a hospital or to the company that made the product. You can also report them to Health Canada through the Canada Vigilance Program or by phone at 1-866-234-2345.

New class IV medical devices approved in 2020

Figure 16: New Class IV medical devices approved in 2020
Figure 16: New Class IV medical devices approved in 2020
Figure 16: New Class IV medical devices approved in 2020: Text description

Number of new Class IV medical devices approved in 2019, according to the Global Medical Device Nomenclature (GMDN) system for naming and grouping medical devices.

Health Category Number of Class IV medical devices approved
Body fluid and tissue management devices 2
Body tissue manipulation and reparation devices 4
Cardiovascular devices 33
Gastro-urological devices 1
General hospital devices 3
In vitro diagnostic medical devices 8
Neurological devices 2
Plastic surgery and cosmetic devices 1
Radiological devices 1

Body fluid and tissue management devices

For example, blood separation systems.

2 New medical devices

CliniMACS Prodigy T Cell Transduction (TCT) System
Sonopet iQ Ultrasonic Aspirator System

Decision summary: Sonopet iQ Ultrasonic Aspirator System

Body tissue manipulation and reparation devices

For example, bone grafts and dermal dressings.

4 New medical devices

Chondro-Gide Bilayer Collagen Membrane

Decision summary: Chondro-Gide Bilayer Collagen Membrane

Myriad

Decision summary: Myriad

Puracol Plus

Decision summary: Puracol Plus

Regeneten Bioinductive Implant System

Decision summary

Cardiovascular devices

For example, cardiovascular catheters and pacemakers.

33 new medical devices

Agilis HisPro Steerable Catheter with Electrodes
Athletis Over-the-Wire PTA Balloon Dilatation Catheter
Attain Stability Quad MRI SureScan 4798

Decision summary: Attain Stability Quad MRI SureScan 4798

Cardiac Resynchronization Therapy Defibrillator (CRT-DS)
Cobalt XT / Cobalt / Crome ICD and CRT-D MRI SureScan

Decision summary: Cobalt XT / Cobalt / Crome ICD and CRT-D MRI SureScan

Diamondback 360 Coronary Orbital Atherectomy System
Eluvia Over-the-Wire Drug-Eluting Vascular Stent System

Decision summary

EPstar Fixed Electropysiology Catheter / Epstar Electrophysiologt Cable

Decision summary

Evolut PRO+ Transcatheter Aortic Valve

Decision summary: Evolut PRO+ Transcatheter Aortic Valve

Implantable Cardioverter Defibrillator (ICDS)
IntellaNav ST

Decision summary

IntellaNav StablePoint Ablation Catheter

Decision summary

Jade PTA Balloon Dilatation Catheter
Konect Resilia Aortic Valved Conduit

Decision summary: Konect Resilia Aortic Valved Conduit

Lotus Edge Valve System

Decision summary

Micra AV MC1AVR1
Penumbra LP Coil System
QDot Micro Navigation Catheter

Decision summary: QDot Micro Navigation Catheter

Ranger and Ranger SL Over-the-Wire Paclitaxel-Coated PTA Balloon Catheter

Decision summary

Reprocessed ViewFlex Xtra ICE Catheter
Sapphire II NC Coronary Dilatation Catheter
Scoreflex NC Coronary Dilatation Catheter
Scoreflex PTA Balloon Dilatation Catheter
Sentinel Cerebral Protection System

Decision summary

Smart Touch Programming System
Surpass Evolve Flow Diverter System
Synergy Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System
Synergy XD Monorail Everolimus-Eluting Platinum Chromium Coronary Stent System
TriClip System

Decision summary

Vega endocardial pacing lead

Decision summary

Wattson temporary pacing guidewire

Decision summary

Xience ProA Everolimus Eluting Coronary Stent System

Decision summary: Xience ProA Everolimus Eluting Coronary Stent System

Zoll X Series Advanced

Decision summary: Zoll X Series Advanced

Gastro-urological devices

For example, incontinence control system.

1 new medical device

InterStim Micro SureScan MRI

Safety update

General hospital devices

For example, infusion pumps.

3 new medical devices

EPstar Fixed Electrophysiology Catheter with Lumen / EPstar Electrophysiology Cable

Decision summary

Minimed 770G

Decision summary

T:slim X2 Insulin Pump with Control-IQ Technology

Decision summary

Safety updates

Respirators:

In vitro diagnostic medical devices

For example, instrument/analyser and viral infection disease in vitro devices.

8 new medical devices

Advia Centaur HBC Total 2 (HBcT2) (donor screening for transplantation)

Decision summary

Advia Centaur Quantitative HBsAg (QHBs)
Alinity s HIV Ag/Ab Combo Assay (donor screening and cadaveric testing)

Decision summary

Atellica IM Quantitative HBsAg (QHBs)
INSTI HIV Self Test

Decision summary

Liaison XL Murex HCV AB

Decision summary

PK CMV-PA System Control Set

Decision summaryPK CMV-PA System Control Set

PK7400 TP HA reagent and controls

Decision summary

Neurological devices

For example, neurological stimulation devices.

2 new medical devices

Percept PC
Proclaim Implantable Pulse Generators

Plastic surgery and cosmetic devices

For example, breast implants.

1 new medical device

Natrelle Inspira Cohesive Breast Impant

Radiological devices

For example, ultrasound imaging systems.

1 new medical device

Acist HDi System

Decision summary: Acist HDi System

Various

Applicable to medical devices generally.

Safety update

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