PMA P030054S025
- Device
- EPIC HF & EPIC II HF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (MODEL V-355) AND MODEL 3307 V.6.1M SOFTWARE
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S025
- Product code
- NIK
- Decision date
- 2006-04-28
- 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 3307 V.6.1M PROGRAMMER SOFTWARE.
Current openFDA PMA Record#
- Device
- EPIC HF & EPIC II HF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (MODEL V-355) AND MODEL 3307 V.6.1M SOFTWARE
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S025
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2006-04-28
- Decision code
- APPR
- Date received
- 2006-03-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MODEL 3307 V.6.1M PROGRAMMER SOFTWARE.