PMA P150035S042

Device: AVEIR VR Real-World Evidence Study
Applicant: ABBOTT MEDICAL
PMA number: P150035
Supplement: S042
Product code: PNJ
Decision date: 2026-10-21
Classification: Cardiovascular
Generic name: Leadless pacemaker
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P150035/S041.

Current openFDA PMA Record#

Device: AVEIR VR Real-World Evidence Study
Applicant: ABBOTT MEDICAL
PMA number: P150035
Supplement: S042
Product code: PNJ
Generic name: Leadless pacemaker
Decision date: 2026-10-21
Decision code: APPR
Date received: 2026-09-25
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P150035/S041.