PMA P030054S031
- Device
- EPIC HF V-338
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S031
- Product code
- NIK
- Decision date
- 2006-07-11
- 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 ST. JUDE MEDICAL ATLAS II/II+ VR/DR/HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM. THE ATLAS II/II+ DEVICES ARE SUPPORTED BY THE MODEL 3510 PROGRAMMER WITH MODEL 3307 V6.1 (OR HIGHER) PROGRAMMER SOFTWARE OR THE MERLIN PATIENT CARE SYSTEM MODEL 3650 WITH MODEL 3330 V3.0 (OR HIGHER) PROGRAMMER SOFTWARE.
Current openFDA PMA Record#
- Device
- EPIC HF V-338
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S031
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2006-07-11
- Decision code
- APPR
- Date received
- 2006-06-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ST. JUDE MEDICAL ATLAS II/II+ VR/DR/HF IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM. THE ATLAS II/II+ DEVICES ARE SUPPORTED BY THE MODEL 3510 PROGRAMMER WITH MODEL 3307 V6.1 (OR HIGHER) PROGRAMMER SOFTWARE OR THE MERLIN PATIENT CARE SYSTEM MODEL 3650 WITH MODEL 3330 V3.0 (OR HIGHER) PROGRAMMER SOFTWARE.