PMA P030054S380

Device: Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/ II+
Applicant: ABBOTT MEDICAL
Product code: NIK
Decision date: 2020-09-22
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: Approval for a shelf-life extension from 6-months to 24-months for Avant, Gallant, Entrant, and Neutrino NxT Family of ICDs and CRT-Ds.

Current openFDA PMA Record#

Device: Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/ II+
Applicant: ABBOTT MEDICAL
PMA number: P030054
Supplement: S380
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2020-09-22
Decision code: APPR
Date received: 2020-07-07
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for a shelf-life extension from 6-months to 24-months for Avant, Gallant, Entrant, and Neutrino NxT Family of ICDs and CRT-Ds.