PMA P150035S033
- Device
- Aveir VR Leadless Pacemaker; Aveir Leadless Pacemaker (Right Atrium); Aveir Leadless Pacemaker (Right Ventricle)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S033
- Product code
- PNJ
- Decision date
- 2025-10-28
- Classification
- Cardiovascular
- Generic name
- Leadless pacemaker
- Approval order statement
- adding automated X-ray inspection testing of solder joints for the Aveir hybrid
Current openFDA PMA Record#
- Device
- Aveir VR Leadless Pacemaker; Aveir Leadless Pacemaker (Right Atrium); Aveir Leadless Pacemaker (Right Ventricle)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S033
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2025-10-28
- Decision code
- OK30
- Date received
- 2025-09-29
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- adding automated X-ray inspection testing of solder joints for the Aveir hybrid