PMA P030054S394

Device: Quadra Assura MP, Quadra Assura, Unify Assura
Applicant: ABBOTT MEDICAL
Product code: NIK
Decision date: 2021-09-15
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
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: Quadra Assura MP, Quadra Assura, Unify Assura
Applicant: ABBOTT MEDICAL
PMA number: P030054
Supplement: S394
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
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.