PMA P030054S199
- Device
- EPIC HF/ATLAS+HF/PROMOTE FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S199
- Product code
- NIK
- Decision date
- 2011-09-28
- 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 3300 VERSION 12.1.10 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.
Current openFDA PMA Record#
- Device
- EPIC HF/ATLAS+HF/PROMOTE FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S199
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2011-09-28
- Decision code
- APPR
- Date received
- 2011-08-31
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MODEL 3300 VERSION 12.1.10 SOFTWARE FOR THE MODEL 3650 MERLIN PATIENT CARE SYSTEM.