Aveir Leadless Pacemaker- Right Atrial, Aveir Leadless Pacemaker- Right Ventricular,
FDA premarket approval P150035/S020 · decided 2024-11-22
Approval details
- PMA number
- P150035
- Supplement
- S020
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Aveir Leadless Pacemaker- Right Atrial, Aveir Leadless Pacemaker- Right Ventricular,
- Generic name
- Leadless pacemaker
- Applicant
- ABBOTT MEDICAL
- Date received
- 2024-10-25
- Decision date
- 2024-11-22
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- PNJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- 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
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510(k) clearances by this applicant
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