PMA P030054S181
- Device
- EPIC HF/ATLAS+HF/PROMOTE/UNIFY FAMILIES OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S181
- Product code
- NIK
- Decision date
- 2011-06-21
- 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 SOFTWARE MODEL MN5000 V.5.0 FOR USE ON THE MERLIN.NET SYSTEM AND MODEL EX2000 V.5.0 FOR USE ON MERLIN@ HOME DEVICES.
Current openFDA PMA Record#
- Device
- EPIC HF/ATLAS+HF/PROMOTE/UNIFY FAMILIES OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S181
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2011-06-21
- Decision code
- APPR
- Date received
- 2011-03-14
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE MODEL MN5000 V.5.0 FOR USE ON THE MERLIN.NET SYSTEM AND MODEL EX2000 V.5.0 FOR USE ON MERLIN@ HOME DEVICES.