List of medical devices that are no longer covered by an exceptional use authorisation
Updated 10 December 2024
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Medical devices that are no longer covered by an exceptional use authorisation are listed below.
Manufacturer: Getinge Ltd Maquet Cardiopulmonary GmbH
Extra Corporeal Membrane Oxygenation (ECMO) items produced by Getinge (HLS Set Advanced, the HIT Set Advanced and the PLS Sets)
Issue date: 25 March 2024
Expiry date: 30 September 2024 - extension issued
MHRA reference number: DEU/012/2023/002
Getinge (on behalf of Maquet Cardiopulmonary GmbH)
HLS and PLS sets
Issue Date: 25 March 2024
Expiry Date: 30 September 2024 - Extension issued
MHRA reference number: DEU/004/2023/003
Manufacturer: Inspire Medical Systems, Inc.
Device model/name: Hypoglossal Nerve Stimulation System Leads Stimulation Lead model number 4063 and Sense Lead model number 4340
Issue Date: 26 March 2024
Expiry Date: 26 September 2024
MHRA reference number: DEU/001/2024/001