- Device
- Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure, Quadra Allure MP
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S207
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2024-12-19
- Decision code
- OK30
- Date received
- 2024-11-25
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- to update electrical/ and software tests performed during manufacturing of pulse generators