PMA P030054S196
- Device
- EPIC HF/ATLAS + HF FAMILY
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S196
- Product code
- NIK
- Decision date
- 2012-03-09
- 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 FOR THE ADDITION OF THE CORVUE THORACIC IMPEDANCE MONITORING FEATURE IN THE UNIFY, FORTIFY AND QUADRA FAMILY OF DEVICES.
Current openFDA PMA Record#
- Device
- EPIC HF/ATLAS + HF FAMILY
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S196
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2012-03-09
- Decision code
- APPR
- Date received
- 2011-07-19
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF THE CORVUE THORACIC IMPEDANCE MONITORING FEATURE IN THE UNIFY, FORTIFY AND QUADRA FAMILY OF DEVICES.