PMA P910023S439

Device: Ellipse VR DR, Fortify Assura VR DR
Applicant: ABBOTT MEDICAL
Product code: LWS
Decision date: 2021-09-15
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: Approval for model line extensions in the Endurity, Endurity Core, Zenex, Zenus, Zenex MRI, and Zenus MRI families of pacemakers; the Quadra Assura MP, Quadra Assura, and Unify Assura families of CRT-Ds; and the Ellipse VR DR and Fortify Assura VR DR family of ICDs. This supplement also requested approval for the MR conditional labeling of a subset of these devices.

Current openFDA PMA Record#

Device: Ellipse VR DR, Fortify Assura VR DR
Applicant: ABBOTT MEDICAL
PMA number: P910023
Supplement: S439
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2021-09-15
Decision code: APPR
Date received: 2021-07-08
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for model line extensions in the Endurity, Endurity Core, Zenex, Zenus, Zenex MRI, and Zenus MRI families of pacemakers; the Quadra Assura MP, Quadra Assura, and Unify Assura families of CRT-Ds; and the Ellipse VR DR and Fortify Assura VR DR family of ICDs. This supplement also requested approval for the MR conditional labeling of a subset of these devices.