PMA P030054S304
- 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
- S304
- Product code
- NIK
- Decision date
- 2016-07-25
- 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 modifications to the Merlin.net MN6000 HF Web Application v9.0 software.
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
- S304
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2016-07-25
- Decision code
- APPR
- Date received
- 2016-04-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software modifications to the Merlin.net MN6000 HF Web Application v9.0 software.