PMA P030035S189

Device: Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps
Applicant: ABBOTT MEDICAL
PMA number: P030035
Supplement: S189
Product code: NKE
Decision date: 2022-05-17
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: Approval for Merlin Patient Care System (PCS) 3650 Model 3330 v25.8.1 software and Merlin 2 PCS Model MER3400 vl.8.1 software to improve the accuracy of the remaining battery longevity estimate by the programmer.

Current openFDA PMA Record#

Device: Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps
Applicant: ABBOTT MEDICAL
PMA number: P030035
Supplement: S189
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2022-05-17
Decision code: APPR
Date received: 2022-03-07
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for Merlin Patient Care System (PCS) 3650 Model 3330 v25.8.1 software and Merlin 2 PCS Model MER3400 vl.8.1 software to improve the accuracy of the remaining battery longevity estimate by the programmer.