PMA P030054S389

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: 2021-09-15
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: Approval for the Merlin 2 PCS Programmer Model MER3700 with Model MER3400 Software.

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: S389
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2021-09-15
Decision code: APPR
Date received: 2021-01-19
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the Merlin 2 PCS Programmer Model MER3700 with Model MER3400 Software.