PMA P030054

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: S402
Product code: NIK
Decision date: 2026-07-21
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: approval for Merlin 2 Patient Care System (PCS) programmer support for the AVEIR Leadless Pacemakers.

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: S440
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2026-07-21
Decision code: APPR
Date received: 2025-12-30
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for Merlin 2 Patient Care System (PCS) programmer support for the AVEIR Leadless Pacemakers.