PMA P030054S109
- Device
- EPIC HF/ATLAS + HF FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S109
- Product code
- NIK
- Decision date
- 2008-11-26
- 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 MINOR CHANGES TO THE XENA CONTROLLER INTEGRATED CIRCUIT CHIP IN THE CURRENT AND PROMOTE ICD/CRT-D DEVICES.
Current openFDA PMA Record#
- Device
- EPIC HF/ATLAS + HF FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S109
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2008-11-26
- Decision code
- APPR
- Date received
- 2008-11-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MINOR CHANGES TO THE XENA CONTROLLER INTEGRATED CIRCUIT CHIP IN THE CURRENT AND PROMOTE ICD/CRT-D DEVICES.