PMA P030054S340
- Device
- Promote/+/RF/Q. Promote Accel, Promote Quadra, Unity, Unity Assura, Unity Quadra, Quadra Assura , Epic+/HF/HF+/ II HF, A
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S340
- Product code
- NIK
- Decision date
- 2017-11-09
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Approval for a software update to the Merlin PCS Programmer software version 24.0.1 Rev. 1 and pacemaker firmware update.
Current openFDA PMA Record#
- Device
- Promote/+/RF/Q. Promote Accel, Promote Quadra, Unity, Unity Assura, Unity Quadra, Quadra Assura , Epic+/HF/HF+/ II HF, A
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S340
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2017-11-09
- Decision code
- APPR
- Date received
- 2017-10-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a software update to the Merlin PCS Programmer software version 24.0.1 Rev. 1 and pacemaker firmware update.