PMA P030035
- Device
- Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S191
- Product code
- NKE
- Decision date
- 2026-04-24
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- the Merlin PCS Programmer Software Model 3330 version 28.8.1
Current openFDA PMA Record#
- Device
- Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S212
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2026-04-24
- Decision code
- APPR
- Date received
- 2026-01-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- the Merlin PCS Programmer Software Model 3330 version 28.8.1