Aveir VR and DR Delivery Catheters
FDA premarket approval P150035/S024 · decided 2025-07-02
Approval details
- PMA number
- P150035
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Aveir VR and DR Delivery Catheters
- Generic name
- Leadless pacemaker
- Applicant
- ABBOTT MEDICAL
- Date received
- 2025-04-07
- Decision date
- 2025-07-02
- Days to decision
- 86 days
- Decision code
- APPR
- Product code
- PNJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- modifications to torque shaft, tether guide, and other minor manufacturing processes for the Aveir VR and DR Delivery Catheters
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510(k) clearances by this applicant
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| Disposable Radiofrequency Cannula (K253907) | ABBOTT MEDICAL | 2026-04-16 |
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| Assert-IQ (DM5100) (K253516) | ABBOTT MEDICAL | 2025-12-18 |