PMA P150035S031
- Device
- AVEIR Leadless Pacemaker
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S031
- Product code
- PNJ
- Decision date
- 2025-09-05
- Classification
- Cardiovascular
- Generic name
- Leadless pacemaker
- Approval order statement
- approval of the revised protocol for the post-approval study (PAS) submitted to comply with the conditions of approval outlined in our approval order P910023/S468
Current openFDA PMA Record#
- Device
- AVEIR Leadless Pacemaker
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S031
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2025-09-05
- Decision code
- APPR
- Date received
- 2025-08-14
- 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) submitted to comply with the conditions of approval outlined in our approval order P910023/S468