- Device
- Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S382
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2020-10-28
- Decision code
- APPR
- Date received
- 2020-07-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for minor design changes to the high voltage capacitors used in select families of ICD and CRT-D devices.