PMA P030054S094
- Device
- EPIC HF/ATLAS + HF FAMILY OF CRT-D'S
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S094
- Product code
- NIK
- Decision date
- 2008-06-27
- 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 MODEL 3330 VERSION 6.8.1 SOFTWARE FOR USE ON MODEL 3650 MERLIN PATIENT CARE SYSTEM.
Current openFDA PMA Record#
- Device
- EPIC HF/ATLAS + HF FAMILY OF CRT-D'S
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S094
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2008-06-27
- Decision code
- APPR
- Date received
- 2008-06-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MODEL 3330 VERSION 6.8.1 SOFTWARE FOR USE ON MODEL 3650 MERLIN PATIENT CARE SYSTEM.