PMA P030054S223
- Device
- UNIFY QUADRA CRT-D, UNIFY QUADRA ASSURA
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S223
- Product code
- NIK
- Decision date
- 2012-08-09
- 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 OF MODEL MN5000 VERSION 6.1 SOFTWARE TO BE USED WITH THE MERLIN.NET SYSTEN AND FOR THE MODEL EX2000 VERSION 6.1 SOFTWARE TO BE USED ON MERLIN AT HOME DEVICES.
Current openFDA PMA Record#
- Device
- UNIFY QUADRA CRT-D, UNIFY QUADRA ASSURA
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S223
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2012-08-09
- Decision code
- APPR
- Date received
- 2012-05-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL OF MODEL MN5000 VERSION 6.1 SOFTWARE TO BE USED WITH THE MERLIN.NET SYSTEN AND FOR THE MODEL EX2000 VERSION 6.1 SOFTWARE TO BE USED ON MERLIN AT HOME DEVICES.