PMA P030054S046
- Device
- CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM & EPIC HF
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S046
- Product code
- NIK
- Decision date
- 2006-12-14
- 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 FOR: 1) AN ALTERNATE ELECTROLYTE (TM422) IN THE HIGH VOLTAGE CAPACITOR USED IN THE ST. JUDE MEDICAL EPIC DR/VR/HF, EPIC+ DR/VR AND EPIC II/II + DR/VR/HF DEVICES; AND 2) THE MINOR MODIFICATIONS TO THE CRYSTAL TUNING FORK USED IN EPIC, EPIC+, EPIC II/II +, ATLAS, ATLAS+, ATLAS II/II + DEVICES.
Current openFDA PMA Record#
- Device
- CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM & EPIC HF
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S046
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2006-12-14
- Decision code
- APPR
- Date received
- 2006-11-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR: 1) AN ALTERNATE ELECTROLYTE (TM422) IN THE HIGH VOLTAGE CAPACITOR USED IN THE ST. JUDE MEDICAL EPIC DR/VR/HF, EPIC+ DR/VR AND EPIC II/II + DR/VR/HF DEVICES; AND 2) THE MINOR MODIFICATIONS TO THE CRYSTAL TUNING FORK USED IN EPIC, EPIC+, EPIC II/II +, ATLAS, ATLAS+, ATLAS II/II + DEVICES.