Aveir VR Leadless System
FDA premarket approval P150035/S022 · decided 2025-04-03
Approval details
- PMA number
- P150035
- Supplement
- S022
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Aveir VR Leadless System
- Generic name
- Leadless pacemaker
- Applicant
- ABBOTT MEDICAL
- Date received
- 2025-03-04
- Decision date
- 2025-04-03
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- PNJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- to add an additional mechanical route on one edge of the Aveir hybrid
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