PMA P030054S401

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: 2022-09-30
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: Approval for the Merlin@home transmitter software model EX2000 v9.0 and cybersecurity enhancements.

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: S401
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2022-09-30
Decision code: APPR
Date received: 2022-07-27
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Merlin@home transmitter software model EX2000 v9.0 and cybersecurity enhancements.