PMA P030054S103
- Device
- EPIC HF / ATLAS + FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S103
- Product code
- NIK
- Decision date
- 2008-09-04
- 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 AN ALTERNATE HIGH VOLTAGE CHARGING TRANSFORMER AND ASSOCIATED MINOR DESIGN CHANGES TO THE HVPCB FOR THE CURRENT AND PROMOTE ICDS/CRT-DS.
Current openFDA PMA Record#
- Device
- EPIC HF / ATLAS + FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S103
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2008-09-04
- Decision code
- APPR
- Date received
- 2008-08-19
- Supplement type
- Real-Time Process
- Approval order statement
- APPROVAL FOR AN ALTERNATE HIGH VOLTAGE CHARGING TRANSFORMER AND ASSOCIATED MINOR DESIGN CHANGES TO THE HVPCB FOR THE CURRENT AND PROMOTE ICDS/CRT-DS.