PMA P030054S074
- Device
- EPIC HF/ATLAS + HF FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S074
- Product code
- NIK
- Decision date
- 2007-12-12
- 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 TWO CORRECTIVE FIXES TO ADDRESS A HARDWARE ISSUED THAT CAN LEAVE THE CRT-D AND ICD SYSTEMS LISTED ABOVE IN A POST-SENSE REFRACTORY STATE. FOR DEVICES THAT ARE ALREADY IMPLANTED AND/OR ALREADY MANUFACTURED, CHANGES WILL BE MADE TO THE PROGRAMMER SOFTWARE. DURING A PATIENT FOLLOW-UP VISIT, THE PROGRAMMER WILL INTERROGATE THE DEVICE AND DOWNLOAD FIRMWARE RAM CODE TO CORRECT THE ANOMALOUS CONDITION IF IT OCCURS. FOR NEW DEVICES, A MODIFICATION HAS BEEN MADE TO THE SIO2 CHIP HARDWARE TO CHECK THE SENSE REFRACTORY STATE EVERY TWO SECONDS AND END IT IF APPROPRIATE.
Current openFDA PMA Record#
- Device
- EPIC HF/ATLAS + HF FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S074
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2007-12-12
- Decision code
- APPR
- Date received
- 2007-10-24
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR TWO CORRECTIVE FIXES TO ADDRESS A HARDWARE ISSUED THAT CAN LEAVE THE CRT-D AND ICD SYSTEMS LISTED ABOVE IN A POST-SENSE REFRACTORY STATE. FOR DEVICES THAT ARE ALREADY IMPLANTED AND/OR ALREADY MANUFACTURED, CHANGES WILL BE MADE TO THE PROGRAMMER SOFTWARE. DURING A PATIENT FOLLOW-UP VISIT, THE PROGRAMMER WILL INTERROGATE THE DEVICE AND DOWNLOAD FIRMWARE RAM CODE TO CORRECT THE ANOMALOUS CONDITION IF IT OCCURS. FOR NEW DEVICES, A MODIFICATION HAS BEEN MADE TO THE SIO2 CHIP HARDWARE TO CHECK THE SENSE REFRACTORY STATE EVERY TWO SECONDS AND END IT IF APPROPRIATE.