Ellipse VR DR, Fortify Assura VR DR

FDA premarket approval P910023/S439 · decided 2021-09-15

Approval details

PMA number

P910023

Supplement

S439

Supplement type

Normal 180 Day Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

Ellipse VR DR, Fortify Assura VR DR

Generic name

Implantable cardioverter defibrillator (non-CRT)

Applicant

ABBOTT MEDICAL

Date received

2021-07-08

Decision date

2021-09-15

Days to decision

69 days

Decision code

APPR

Product code

LWS

Advisory committee

Cardiovascular

Expedited review

No

Location

Sylmar, CA

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.

510(k) clearances by this applicant