PMA P030054S043
- Device
- EPIC HF/ATLAS+HF FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S043
- Product code
- NIK
- Decision date
- 2006-11-30
- 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 MODEL 3330 VERSION 5.2 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.3.2 SOFTWARE FOR USE ON THE MODEL 3510 AND 3500 PROGRAMMERS.
Current openFDA PMA Record#
- Device
- EPIC HF/ATLAS+HF FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S043
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2006-11-30
- Decision code
- APPR
- Date received
- 2006-10-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MODEL 3330 VERSION 5.2 SOFTWARE FOR USE ON THE MODEL 3650 MERLIN PATIENT CARE SYSTEM AND THE MODEL 3307 VERSION 6.3.2 SOFTWARE FOR USE ON THE MODEL 3510 AND 3500 PROGRAMMERS.