PMA P030035S208

Device: Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps
Applicant: ABBOTT MEDICAL
PMA number: P030035
Supplement: S208
Product code: NKE
Decision date: 2025-06-17
Classification: Cardiovascular
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Approval order statement: approval for the AVEIR AR 2 LSP203A Leadless Pacemaker (LP), including updates to LP design, labeling, and Merlin PCS Programmer Software 3330 v28.5.x.

Current openFDA PMA Record#

Device: Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps
Applicant: ABBOTT MEDICAL
PMA number: P030035
Supplement: S208
Product code: NKE
Generic name: Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
Decision date: 2025-06-17
Decision code: APPR
Date received: 2025-03-19
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: approval for the AVEIR AR 2 LSP203A Leadless Pacemaker (LP), including updates to LP design, labeling, and Merlin PCS Programmer Software 3330 v28.5.x.