PMA P150035S024
- Device
- Aveir VR and DR Delivery Catheters
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S024
- Product code
- PNJ
- Decision date
- 2025-07-02
- Classification
- Cardiovascular
- Generic name
- Leadless pacemaker
- Approval order statement
- modifications to torque shaft, tether guide, and other minor manufacturing processes for the Aveir VR and DR Delivery Catheters
Current openFDA PMA Record#
- Device
- Aveir VR and DR Delivery Catheters
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S024
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2025-07-02
- Decision code
- APPR
- Date received
- 2025-04-07
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- modifications to torque shaft, tether guide, and other minor manufacturing processes for the Aveir VR and DR Delivery Catheters