- Device
- Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MRI Conditional)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030035
- Supplement
- S182
- Product code
- NKE
- Generic name
- Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
- Decision date
- 2020-10-26
- Decision code
- OK30
- Date received
- 2020-10-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adjust the minimum relative humidity from 40% to 35% in the product packaging area.