PMA P030054S084
- Device
- EPIC HF/ATLAS+HF FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S084
- Product code
- NIK
- Decision date
- 2008-05-02
- 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 MODIFICATIONS TO THE HERCULES 2J ANALOG IO CHIP USED IN THE CURRENT IDC AND PROMOTE CRT-D DEVICES.
Current openFDA PMA Record#
- Device
- EPIC HF/ATLAS+HF FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S084
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2008-05-02
- Decision code
- APPR
- Date received
- 2008-03-19
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE HERCULES 2J ANALOG IO CHIP USED IN THE CURRENT IDC AND PROMOTE CRT-D DEVICES.