PMA P150035
- Device
- Aveir VR (LSCD111); DR Delivery Catheter (LSCD201)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S002
- Product code
- PNJ
- Decision date
- 2026-05-29
- Generic name
- Leadless pacemaker
- Approval order statement
- Approval for a revised design for the AVEIR delivery catheters packaging trays and retainers as well as a shelf-life extension for both delivery catheters.
Current openFDA PMA Record#
- Device
- Aveir VR (LSCD111); DR Delivery Catheter (LSCD201)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S038
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2026-05-29
- Decision code
- APPR
- Date received
- 2026-03-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a revised design for the AVEIR delivery catheters packaging trays and retainers as well as a shelf-life extension for both delivery catheters.