Aveir Leadless System
FDA premarket approval P150035/S023 · decided 2025-06-17
Approval details
- PMA number
- P150035
- Supplement
- S023
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Aveir Leadless System
- Generic name
- Leadless pacemaker
- Applicant
- ABBOTT MEDICAL
- Date received
- 2025-03-19
- Decision date
- 2025-06-17
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- PNJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- approval for the AVEIR AR 2 LSP203A Leadless Pacemaker (LP), including updates to LP design, labeling, and Merlin PCS Programmer Software 3330 v28.5.x.
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