PMA P030054S259
- Device
- PROMOTE,QUADRA ASSURA,UNIFY,UNIFY ASSURA,UNIFY QUADRA FAMILIES OF CRT-D DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S259
- Product code
- NIK
- Decision date
- 2014-03-31
- 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 MODIFICATION IN THE SEPARATOR COMPONENT UTILIZED IN THE BATTERIES OF THE IMPLANTABLE PULSE GENERATORS.
Current openFDA PMA Record#
- Device
- PROMOTE,QUADRA ASSURA,UNIFY,UNIFY ASSURA,UNIFY QUADRA FAMILIES OF CRT-D DEVICES
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S259
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2014-03-31
- Decision code
- APPR
- Date received
- 2014-01-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A MODIFICATION IN THE SEPARATOR COMPONENT UTILIZED IN THE BATTERIES OF THE IMPLANTABLE PULSE GENERATORS.