PMA P030054S045
- Device
- ST. JUDE MEDICAL EPIC II/EPIC II + AND ATLAS II/ATLAS II + ICDS AND CRT-D SYSTEMS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S045
- Product code
- NIK
- Decision date
- 2006-12-13
- 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 FOLLOWING MODIFICATIONS TO THE ICD/CRT-D DEVICE HYBRID: 1) ADDITION OF A NEW C64 MICRO CONTROLLER INTEGRATED CIRCUIT (IC); 2) CHANGES TO THE C46 VSS SUPPLY CAPACITOR FROM 3.3 UF TO 33 UF; AND 3) CHANGES TO DIODES D17, D19 AND D23 IN THE PROTECTION CIRCUIT.
Current openFDA PMA Record#
- Device
- ST. JUDE MEDICAL EPIC II/EPIC II + AND ATLAS II/ATLAS II + ICDS AND CRT-D SYSTEMS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S045
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2006-12-13
- Decision code
- APPR
- Date received
- 2006-11-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE FOLLOWING MODIFICATIONS TO THE ICD/CRT-D DEVICE HYBRID: 1) ADDITION OF A NEW C64 MICRO CONTROLLER INTEGRATED CIRCUIT (IC); 2) CHANGES TO THE C46 VSS SUPPLY CAPACITOR FROM 3.3 UF TO 33 UF; AND 3) CHANGES TO DIODES D17, D19 AND D23 IN THE PROTECTION CIRCUIT.