Decision

List of medical devices given exceptional use authorisations

Updated 20 March 2024

Manufacturer: Thora Tech GmbH

MONSOON high-frequency jet ventilator (Model 4)

Issue date: 6 March 2024

Expiry date: 31 July 2024

MHRA reference number: DEU/011/2023/00

Manufacturer: Medgyn International Inc

Medgyn Word Bartholin Catheter, Medgyn Amniohook and Medgyn Post-partum balloon catheter

Issue date: 25 January 2024

Expiry date: 25 July 2024

MHRA reference number: DEU/011/2023/001

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: 21 December 2023

Expiry date: 27 March 2024

MHRA reference number: DEU/012/2023/002

Manufacturer: Medtronic Ltd

Permacol Surgical Implant

Issue date: 22 August 2023

Expiry date: 24 February 2024

MHRA reference number: DEU/001/2023/003

Manufacturer: Smiths Medical ASD, Inc.

Pain Management Kits - Combined Spinal Epidural, Epidural, Peripheral Nerve Block and Spinal kits

Issue Date: 14 August 2023

Expiry Date: 14 February 2024

MHRA reference number: DEU/011/2022/007

Manufacturer: Medtronic Ltd

Medtronic Spinal Cord Stimulation Extensions and Accessories, Model Numbers: 37082-20, 37082-60, 37083-20, 37083-60, 3550-29, 3887-45, 3888-28 and 3888-45 ONLY.

Issue Date: 25 July 2023

Expiry Date: 31 January 2024

MHRA reference number: DEU/003/2023/001

Manufacturer: Medtronic Ltd

Pocket Adaptor (model 64002) and Medical Adhesive Kit (080118)

Issue Date: 14 August 2023

Expiry Date: 24 February 2024

MHRA reference number: DEU/012/2022/021

Getinge (on behalf of Maquet Cardiopulmonary GmbH)

HLS and PLS sets

Issue Date: 30 June 2023

Expiry Date: 27 March 2024 - Extension issued

MHRA reference number: DEU/004/2023/003

Manufacturer: Integra Lifesciences Ltd

Licox Probes and Introducers

Issue Date: 14 June 2023

Expiry Date: 31 May 2024 - Extension issued

MHRA reference number: DEU/011/2022/003

Manufacturer: Numed Inc

SPECIAL USE OF CP COVERED STENTS FOR TREATMENT OF SINUS VENOSUS ASD

Issue Date: 24 March 2021

Expiry Date: 31 October 2023

MHRA reference number: DEU/002/2021/001

Manufacturer: HeartWave Inc (Medtronic Ltd)

The Heartware HVAD (model number 1104) System

Issue Date: 10 March 2023

Expiry Date: 27 March 2024 - Extension issued

MHRA reference number: DEU/012/2022/006

Manufacturer: Integra Lifesciences Ltd

NeuroBalloon

Issue Date: 21 December 2022

Expiry date: 30 September 2024 - Extension issued

MHRA reference number: DEU/011/2022/002

Manufacturer: Becton, Dickinson & Company

BD BodyGuard™ Accessory Products - ‘Bolus Cable’

Issue Date: 3 November 2022

Expiry Date: 1 April 2024 - Extension issued

MHRA reference number: DEU/008/2022/015

Manufacturer: Edare Inc

Device/model name: Wireless Automated hearing Test System WAHTS AC1

Issue date: 8 February 2022

Expiry date: 30 January 2024 – Extension Issued

MHRA reference number: DEU/012/2021/002

Manufacturer: Vygon GmbH

Device/model name: Catheters and other single use medical devices (various)

Issue date: 10 August 21

Expiry date: 31 May 2024 – Extension Issued

MHRA reference number: DEU/007/2021/003

Manufacturer: Becton, Dickinson & Company

Device/model name: BD BodyComm™

Issue date: 11 May 2022

Expiry Date: 25 July 2024 - Extension issued

MHRA reference number: DEU/004/2022/003

Manufacturer: BioAccess, Inc

Device model/name: MH-2150—Marrow Collection System

Issue Date: 6 October 2022

Expiry Date: 4 June 2024 - Extension issued

MHRA reference number: DEU/009/2022/005

Manufacturer: Edwards Lifesciences LLC

Device model/name: Atrioseptostomy Catheters

Issue Date: 1 June 2023

Expiry Date: 27 May 2024 - Extension issued

MHRA reference number: DEU/012/2022/024