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On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

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  6. 2024 Device Approvals
  1. Recently-Approved Devices

The products listed in this section include some of the newest medical technology from the year 2024. The products in each list contain information about what medical uses the device is cleared or approved for, when it can be used, and when it should not be used. This information, along with information from your doctor and other sources, can help make you an informed participant in your health care.

Medical Devices Cleared or Approved by FDA in 2024

Device Name Category Date
Minima Stent System - P240003 Stent 08/28/2024
Altius Direct Electrical Nerve Stimulation System - P230020 Stimulation System 08/26/2024
Shield - P230009 Lab Test 07/26/2024
UNIPURE C3F8 Ophthalmic Gas, UNIFEYE Gas Delivery System, UNIPEXY Gas Delivery System - P220030 Eye Injection 07/02/2024
MYNX CONTROL Venous Vascular Closure Device (VCD) 6F-12F - P040044/S097 Vascular Closure Delivery System 06/27/2024
Abbott Spinal Cord Stimulation (SCS) Systems - P010032/S191 Stimulator 05/30/2024
Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve System - P140031/S162 Heart Valve 05/23/2024
BD Onclarity HPV Assay - P160037/S017 Lab Test 05/14/2024
cobas HPV Test for 4800 System - P100020/S055 Lab Test 05/14/2024
cobas HPV for 5800/6800/8800 Systems - P190028/S009 Lab Test 05/14/2024
ColoSense – P230001 Lab Test 05/03/2024
TriClip G4 System - P230007 Heart Clip Implant 04/01/2024
LIAISON Biotrin Parvovirus B19 IgG Plus, LIAISON Biotrin Control Parvovirus B19 IgG Plus - P220034 Lab Test 03/29/2024
AGENT Paclitaxel-Coated Ballon Catheter - P230035 Catheter 02/29/2024
Vercise PC, Vercise Gevia, and Vercise Genus Deep Brain Stimulation (DBS) System - P150031/S064 Stimulation System 02/29/2024

INTELLANAV STABLEPOINT Ablation Catheter & Force Sensing System on the RHYTHMIA HDX Mapping System - P150005/S074

Catheter 02/26/2024
Xstim Spine Fusion Stimulator – P230025 Stimulator 02/09/2024
XACT Carotid Stent System – P040038/S043 Stent 02/07/2024
Spectra WaveWriter SCS System, WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS Spinal Cord Stimulation Systems - P030017/S363 Stimulation System 02/05/2024
Edwards EVOQUE Tricuspid Valve Replacement System – P230013 Tricuspid Valve Replacement System 02/01/2024

TZ Medical Adult and Pediatric Multi-Function Defibrillation Electrodes and Adaptors – P200005

Defibrillator 01/09/2024

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