PMA P030054S159
- Device
- EPIC/ATLAS/ PROMOTE FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S159
- Product code
- NIK
- Decision date
- 2011-10-20
- 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 NEUTRINO 2, SHIVA, AND SHIVA 2 HIGH VOLTAGE CAPACITORS.
Current openFDA PMA Record#
- Device
- EPIC/ATLAS/ PROMOTE FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S159
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2011-10-20
- Decision code
- APPR
- Date received
- 2010-07-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE NEUTRINO 2, SHIVA, AND SHIVA 2 HIGH VOLTAGE CAPACITORS.