PMA P150035
- Device
- Aveir™ Leadless System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S002
- Product code
- PNJ
- Decision date
- 2026-07-21
- Generic name
- Leadless pacemaker
- Approval order statement
- approval for Merlin 2 Patient Care System (PCS) programmer support for the AVEIR Leadless Pacemakers.
Current openFDA PMA Record#
- Device
- Aveir™ Leadless System
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S035
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2026-07-21
- Decision code
- APPR
- Date received
- 2025-12-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for Merlin 2 Patient Care System (PCS) programmer support for the AVEIR Leadless Pacemakers.