PMA P030035S188
- Device
- Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S188
- Product code
- NKE
- Decision date
- 2022-01-07
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Approval order statement
- Approval for Merlin PCS 3650 Programmer Model 3330 Software v25.41.
Current openFDA PMA Record#
- Device
- Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S188
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2022-01-07
- Decision code
- APPR
- Date received
- 2021-10-18
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for Merlin PCS 3650 Programmer Model 3330 Software v25.41.