- Device
- Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S191
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2022-09-30
- Decision code
- APPR
- Date received
- 2022-07-27
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the Merlin@home transmitter software model EX2000 v9.0 and cybersecurity enhancements.