PMA P030054S286
- Device
- QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S286
- Product code
- NIK
- Decision date
- 2015-07-13
- 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 THE MERLIN@HOME EX1150W/EX1100W-MX (MODEM EXTRACTED) TO BE USED WITH THE DEVICES.
Current openFDA PMA Record#
- Device
- QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S286
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2015-07-13
- Decision code
- APPR
- Date received
- 2015-05-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MERLIN@HOME EX1150W/EX1100W-MX (MODEM EXTRACTED) TO BE USED WITH THE DEVICES.