PMA P030054S301
- Device
- PROMOTE+ QUADRA ASSURA , UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S301
- Product code
- NIK
- Decision date
- 2016-04-21
- 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 a design change to high voltage capacitors.
Current openFDA PMA Record#
- Device
- PROMOTE+ QUADRA ASSURA , UNIFY ASSURA, UNIFY QUADRA FAMILIES OF CRT-D DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S301
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2016-04-21
- Decision code
- APPR
- Date received
- 2016-02-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for a design change to high voltage capacitors.