PMA P030054S329
- Device
- Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/ II HF/ II
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S329
- Product code
- NIK
- Decision date
- 2017-08-23
- 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 cybersecurity updates to the firmware of low voltage devices, cybersecurity updates to the clinician programmer, and updates to the programmer and Merlin.net server to detect rapid battery depletion in high voltage devices.
Current openFDA PMA Record#
- Device
- Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/ II HF/ II
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S329
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2017-08-23
- Decision code
- APPR
- Date received
- 2017-05-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for cybersecurity updates to the firmware of low voltage devices, cybersecurity updates to the clinician programmer, and updates to the programmer and Merlin.net server to detect rapid battery depletion in high voltage devices.