PMA P030035

Device: Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps
Applicant: ABBOTT MEDICAL
PMA number: P030035
Supplement: S191
Product code: NKE
Decision date: 2026-07-21
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: approval for Merlin 2 Patient Care System (PCS) programmer support for the AVEIR Leadless Pacemakers.

Current openFDA PMA Record#

Device: Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps
Applicant: ABBOTT MEDICAL
PMA number: P030035
Supplement: S211
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
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.