PMA P030035S205
- Device
- Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S205
- Product code
- NKE
- Decision date
- 2025-02-05
- Classification
- Cardiovascular
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- approval for a model expansion of the NGQ Family of CRT-Ds with new header configurations
Current openFDA PMA Record#
- Device
- Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S205
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2025-02-05
- Decision code
- APPR
- Date received
- 2024-09-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for a model expansion of the NGQ Family of CRT-Ds with new header configurations