PMA P030054S320
- Device
- Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+H
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S320
- Product code
- NIK
- Decision date
- 2017-10-20
- 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 Merlin.net MN5000 v7.5 Software to add support for the Confirm Rx Insertable Cardiac Monitor.
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+H
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S320
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2017-10-20
- Decision code
- APPR
- Date received
- 2017-02-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for Merlin.net MN5000 v7.5 Software to add support for the Confirm Rx Insertable Cardiac Monitor.