- Device
- Aveir™ VR Leadless System: Aveir™ Leadless Pacemaker (Right Ventricular), Aveir™ Delivery System Catheter, Aveir™ Link M
- Applicant
- ABBOTT MEDICAL
- PMA number
- P150035
- Supplement
- S001
- Product code
- PNJ
- Generic name
- Leadless pacemaker
- Decision date
- 2022-05-04
- Decision code
- OK30
- Date received
- 2022-04-18
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Updating the docking button cleaning line from manual to an automated cleaning system.