PMA P030054S287
- 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
- S287
- Product code
- NIK
- Decision date
- 2015-09-16
- 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 V8.1.1 SOFTWARE FOR MODELS EX1150, EX1150W, EX1100, AND EX1100W TRANSMITTERS.
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
- S287
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2015-09-16
- Decision code
- APPR
- Date received
- 2015-07-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR UPDATES TO THE MERLIN@HOME EX2000 V8.1.1 SOFTWARE FOR MODELS EX1150, EX1150W, EX1100, AND EX1100W TRANSMITTERS.