PMA P030054S002
- Device
- ST JUDE MEDICAL EPIC HF MODEL V-338 AND ATLAS + HF MODEL V-340 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S002
- Product code
- NIK
- Decision date
- 2005-01-14
- 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 OF THE POST-APPROVAL STUDY FOR YOUR DEVICE.
Current openFDA PMA Record#
- Device
- ST JUDE MEDICAL EPIC HF MODEL V-338 AND ATLAS + HF MODEL V-340 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS)
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S002
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2005-01-14
- Decision code
- APPR
- Date received
- 2004-08-16
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- APPROVAL OF THE POST-APPROVAL STUDY FOR YOUR DEVICE.