PMA P150035S029
- Device
- AVEIR™ AR 2 LSP203A Leadless Pacemaker (LP) (atrial)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S029
- Product code
- PNJ
- Decision date
- 2025-08-15
- Classification
- Cardiovascular
- Generic name
- Leadless pacemaker
- Approval order statement
- approval of version E of the protocol for the post-approval study (PAS) referenced above
Current openFDA PMA Record#
- Device
- AVEIR™ AR 2 LSP203A Leadless Pacemaker (LP) (atrial)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S029
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2025-08-15
- Decision code
- APPR
- Date received
- 2025-07-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- approval of version E of the protocol for the post-approval study (PAS) referenced above