FDA Output April 2022

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ARTICLE SUMMARY:

Novel FDA Device Approvals, Breakthrough Designations, Class I Recalls, Warning Letters, and new Diagnostic Emergency Use Authorizations in April 2022. Updated April 30.

A roundup of FDA’s actions in April 2022.

NOVEL DEVICE APPROVALS

Company

Device

Date

Approval Type

Approval Number

Biosensors international
 

biofreedom drug coated coronary stent system

4/14/22

Original PMA

P190020

Vascutek

biofreedom drug coated coronary stent system

4/19/21

Original PMA

P210006

TransMedics ocs heart system 4/27/22 Panel-track supplement
  P180051 S001
Silk Road Medical enroute transcarotid stent system 4/28/22 Panel-track supplement
  P140026 S016
  BioFire Diagnostics
BioFire Joint Infection (JI) Panel 4/29/22 De Novo DEN200066

BREAKTHROUGH DEVICES

Sponsor

Device

Clinical Target

Date

Bridge to Life

LifeCradle Heart Preservation Transport System

Heart preservation and transportation

4/21/22

Quanterix

Simoa neurofilament light chain (NfL) plasma test

Relapsing-remitting MS

4/22/22

Nocira Nocira AVPI system Migraine 4/27/22

WARNING LETTERS

Company

Citations

Posting Date

Issuing Office

Skin Sheek

Premarket

4/5/22

OHT4: Office of Surgical and Infection Control Devices

CLASS 1 RECALLS

Company

Device

Date

Recall Number

Sensory Medical

Cub 2 Enclosed Bed Canopy System

4/14/22

 
 

Z-0918-2022

 

   

Medtronic

Harmony Delivery Catheter System

4/18/22

Z-0927-2022

Respironics California

Philips Respironics V680 Ventilator (All Models)
 

4/18/22

 

Z-0909-2022

Respironics California

Philips Respironics V60 Ventilator (All Models)

4/18/22

 

Z-0907-2022

Respironics California

Philips Respironics V60 Plus Ventilator (All Models)

4/18/22

 

Z-0908-2022

Covidien

Puritan Bennett 980 Series Ventilator

4/25/22

Z-0966-2022

Celltrion Celltrion DiaTrust COVID-19 Ag Rapid Test
4/27/22
  Z-0953-2022

NEW DIAGNOSTIC EMERGENCY USE AUTHORIZATIONS

Test Kit Manufacturer & Commercial Labs

Date Issued

OSANG,OHC COVID-19 Antigen Self Test

4/6/22

DC Department of Health,Test Yourself DC At-Home COVID-19 Collection Kit

4/6/22

Xiamen Boson Biotech,Rapid SARS-CoV-2 Antigen Test Card

4/7/22

UCSD BCG EXCITE Lab, UCSD EXCITE COVID-19 EL Test

4/7/22

Cleveland Clinic Tomsich Institute,SelfCheck cobas SARS-CoV-2 + Flu Assay

4/11/22

MicroGEM US,MicroGEM Sal6830 SARS-CoV-2 Saliva Test

4/14/22

OPTI Medical Systems,OPTI SARS-CoV-2/ Influenza A/B RT-PCR Test (Version 1 and Version 2) 

4/21/22

Audere, HealthPulse@home Fusion 4/26/22
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