PMA P030035S198

Device: Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps
Applicant: ABBOTT MEDICAL
PMA number: P030035
Supplement: S198
Product code: NKE
Decision date: 2025-04-01
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: approval for the Merlin 2 Patient Care System (PCS) Programmer MER3700 with software Model MER3400 v1.9.1 and Merlin Live Connect Software, Model MLC1000.

Current openFDA PMA Record#

Device: Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps
Applicant: ABBOTT MEDICAL
PMA number: P030035
Supplement: S198
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2025-04-01
Decision code: APPR
Date received: 2023-12-29
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for the Merlin 2 Patient Care System (PCS) Programmer MER3700 with software Model MER3400 v1.9.1 and Merlin Live Connect Software, Model MLC1000.