PMA P150035
- Device
- Aveir VR Leadless System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S002
- Product code
- PNJ
- Decision date
- 2026-08-27
- Generic name
- Leadless pacemaker
- Approval order statement
- approval for the AVEIR VR LSP203V Leadless Pacemaker (LP).
Current openFDA PMA Record#
- Device
- Aveir VR Leadless System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S041
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2026-08-27
- Decision code
- APPR
- Date received
- 2026-05-29
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for the AVEIR VR LSP203V Leadless Pacemaker (LP).