- Device
- Victory 5816, 5810, 5610; Zephyr 5820, 5826, 5620, 5626; Accent PM1110, PM1210, PM2110, PM2210; Assurity PM1240, PM2240;
- Applicant
- ABBOTT MEDICAL
- PMA number
- P880086
- Supplement
- S288
- Product code
- DXY
- Generic name
- implantable pacemaker Pulse-generator
- Decision date
- 2017-10-16
- Decision code
- OK30
- Date received
- 2017-09-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Automation of the tray packaging inspection process to ensure the required components are in the tray.