PMA P150035S026

Device: Aveir™ VR Leadless Pacemaker, Aveir™ Leadless Pacemaker (Right Ventricular)
Applicant: ABBOTT MEDICAL
PMA number: P150035
Supplement: S026
Product code: PNJ
Decision date: 2026-02-19
Classification: Cardiovascular
Generic name: Leadless pacemaker
Approval order statement: an alternative sterilization site (Cycle 100 in Chamber 1 and 2, Abbott, Arecibo, PR) for analytical test articles (non-finished goods) comprising several cardiac leads and Aveir Leadless Pacemakers Monolithic Controlled Release Devices (MCRDs)

Current openFDA PMA Record#

Device: Aveir™ VR Leadless Pacemaker, Aveir™ Leadless Pacemaker (Right Ventricular)
Applicant: ABBOTT MEDICAL
PMA number: P150035
Supplement: S026
Product code: PNJ
Generic name: Leadless pacemaker
Decision date: 2026-02-19
Decision code: APPR
Date received: 2025-05-12
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: an alternative sterilization site (Cycle 100 in Chamber 1 and 2, Abbott, Arecibo, PR) for analytical test articles (non-finished goods) comprising several cardiac leads and Aveir Leadless Pacemakers Monolithic Controlled Release Devices (MCRDs)