PMA P030035S151
- Device
- ANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-PS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S151
- Product code
- NKE
- Decision date
- 2017-01-31
- Classification
- Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (crt-p)
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Approval for software updates to the Merlin@home v8.2.2 to increase the cybersecurity of the system.
Current openFDA PMA Record#
- Device
- ANTHEM, ALLURE/RF, ALLURE QUADRA/RF FAMILY OF CRT-PS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S151
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2017-01-31
- Decision code
- APPR
- Date received
- 2016-12-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software updates to the Merlin@home v8.2.2 to increase the cybersecurity of the system.