Aveir Leadless System (Dual-Chamber)
FDA premarket approval P880086/S337 · decided 2024-09-25
Approval details
- PMA number
- P880086
- Supplement
- S337
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Aveir Leadless System (Dual-Chamber)
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- ABBOTT MEDICAL
- Date received
- 2024-06-28
- Decision date
- 2024-09-25
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- approval for a new dual-chamber functional operating mode (AAI(R)+VVI) for the Aveir DR Leadless Pacing System
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