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Medtronic Australasia Pty Ltd - Puritan Bennett™ 980 Series Ventilators - Ventilator, adult (221416)

ARTG ID 221416

ARTG Name
Medtronic Australasia Pty Ltd - Puritan Bennett™ 980 Series Ventilators - Ventilator, adult
Product name
Puritan Bennett™ 980 Series Ventilators - Ventilator, adult
ARTG Date
Registration Type
Device
Therapeutic good type
Medical devices
Sponsor
Medtronic Australasia Pty Ltd
Manufacturers
Covidien llc
Licence category
INC
Licence status
A
Licence class
Class IIb
Summary
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Related information

  • Puritan Bennett 980 Series Ventilator (Suspended from the ARTG for a 6 month period under section 41GA(1)(a)(i) of the Act)

    Cancellation or suspension
    Regulatory action due to Pursuant to section 41GA(1)(a)(i) of the Act, there is a potential risk of death, serious illness or serious injury if the Device continues to be included in the Register and pursuant to section 41GA(I)(b) of the Act it is likely that Medtronic Australasia Pty Ltd will, within the 6 month period of suspension, be able to take the action necessary to ensure that the Device would not cause a potential risk of death, serious illness or serious injury if it were to continue to be included in the Register., effective 05/02/2018

  • Puritan Bennett 980 Series Ventilator (Suspended from the ARTG for a 6 month period under section 41GN(1)(a)(i) of the Act)

    Cancellation or suspension
    Regulatory action due to Pursuant to section 41GA(1)(a)(i) of the Act, there is a potential risk of death, serious illness or serious injury if the Device continues to be included in the Register and pursuant to section 41GA(I)(b) of the Act it is likely that Medtronic Australasia Pty Ltd will, within the 6 month period of suspension, be able to take the action necessary to ensure that the Device would not cause a potential risk of death, serious illness or serious injury if it were to continue to be included in the Register., effective 05/02/2018