Aveir DR Leadless System
FDA premarket approval P150035/S003 · decided 2023-06-29
Approval details
- PMA number
- P150035
- Supplement
- S003
- Supplement type
- Panel Track
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Aveir DR Leadless System
- Generic name
- Leadless pacemaker
- Applicant
- ABBOTT MEDICAL
- Date received
- 2023-01-17
- Decision date
- 2023-06-29
- Days to decision
- 163 days
- Decision code
- APPR
- Product code
- PNJ
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Sylmar, CA
- Statement
- Approval for the Aveir DR Leadless System, Aveir Leadless Pacemaker (Right Ventricular), Aveir Leadless Pacemaker (Right Atrial), Aveir Delivery Catheter, Aveir Link Module.
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