PMA P030054S284
- Device
- QUADRA ASSURA / UNIFY ASSURA FAMILY OF CRT-D'S
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S284
- Product code
- NIK
- Decision date
- 2015-08-27
- 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 NEW ENDURITY CORE FAMILY OF PACEMAKERS, THE MERLIN 20.1.1 PCS PROGRAMMER SOFTWARE WHICH SUPPORTS THE NEW DEVICE MODELS, UPDATED MERLINCONDUCT 1.3MOBILE APPLICATION SOFTWARE, AND SUPPORT FOR THE MERLIN ELECTRONIC HEALTH RECORD DIRECTEXPORT FEATURE.
Current openFDA PMA Record#
- Device
- QUADRA ASSURA / UNIFY ASSURA FAMILY OF CRT-D'S
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S284
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2015-08-27
- Decision code
- APPR
- Date received
- 2015-02-11
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE NEW ENDURITY CORE FAMILY OF PACEMAKERS, THE MERLIN 20.1.1 PCS PROGRAMMER SOFTWARE WHICH SUPPORTS THE NEW DEVICE MODELS, UPDATED MERLINCONDUCT 1.3MOBILE APPLICATION SOFTWARE, AND SUPPORT FOR THE MERLIN ELECTRONIC HEALTH RECORD DIRECTEXPORT FEATURE.