PMA P030054S292
- Device
- PROMOTE/+/RF/Q,PROMOTE ACCEL,PROMOTE QUADRA,UNIFY,UNIFY ASSURA,UNIFY QUADRA,QUADRA ASSURA,EPIC+/HF/HF+/IIHF/II+HF,ATLAS+
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S292
- Product code
- NIK
- Decision date
- 2016-05-12
- 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 updates to the Merlin@home EX2000 v8.2 Software and the Merlin.net MN5000 v7.4 Software.
Current openFDA PMA Record#
- Device
- PROMOTE/+/RF/Q,PROMOTE ACCEL,PROMOTE QUADRA,UNIFY,UNIFY ASSURA,UNIFY QUADRA,QUADRA ASSURA,EPIC+/HF/HF+/IIHF/II+HF,ATLAS+
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S292
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2016-05-12
- Decision code
- APPR
- Date received
- 2015-09-15
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for updates to the Merlin@home EX2000 v8.2 Software and the Merlin.net MN5000 v7.4 Software.