PMA P030054S064
- Device
- EPIC HF/ATLAS+HF FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S064
- Product code
- NIK
- Decision date
- 2007-10-05
- 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 SEVERAL SOFTWARE CHANGES FOR VERSION 7.0.74 FOR THE FIRMWARE AND FOR VERSION 6.3.1 FOR THE MODEL 3330 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
Current openFDA PMA Record#
- Device
- EPIC HF/ATLAS+HF FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S064
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2007-10-05
- Decision code
- APPR
- Date received
- 2007-08-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SEVERAL SOFTWARE CHANGES FOR VERSION 7.0.74 FOR THE FIRMWARE AND FOR VERSION 6.3.1 FOR THE MODEL 3330 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.