PMA P030054S316
- Device
- Promote/+/RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY,UNIFY ASSURA, UNIFY QUADRA
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S316
- Product code
- NIK
- Decision date
- 2017-01-31
- 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 software updates to the Merlin@home v8.2.2 to increase the cybersecurity of the system.
Current openFDA PMA Record#
- Device
- Promote/+/RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY,UNIFY ASSURA, UNIFY QUADRA
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S316
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2017-01-31
- Decision code
- APPR
- Date received
- 2016-12-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software updates to the Merlin@home v8.2.2 to increase the cybersecurity of the system.