- Device
- Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S393
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2021-07-07
- Decision code
- OK30
- Date received
- 2021-06-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Adjust Bioburden action limit and alert levels at the Sylmar manufacturing site.