PMA P030054S241
- Device
- QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S241
- Product code
- NIK
- Decision date
- 2014-03-20
- 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 ADDITIONAL ASSURITY+, ASSURITY, AND ENDURITY PACEMAKERS, THEALLURE AND ALLURE QUADRA CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (CRT-P), MODEL 3330 VERSION 17.1.1 SOFTWARE, AND MERLIN PACING SYSTEM ANALYZER (PSA) MODEL EX3100.
Current openFDA PMA Record#
- Device
- QUADRA ASSURA/UNIFY ASSURA FAMILY OF CRT-DS
- Applicant
- ABBOTT MEDICAL
- PMA number
- P030054
- Supplement
- S241
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2014-03-20
- Decision code
- APPR
- Date received
- 2012-12-05
- Supplement type
- Normal 180 Day Track
- Approval order statement
- APPROVAL FOR ADDITIONAL ASSURITY+, ASSURITY, AND ENDURITY PACEMAKERS, THEALLURE AND ALLURE QUADRA CARDIAC RESYNCHRONIZATION THERAPY PACEMAKERS (CRT-P), MODEL 3330 VERSION 17.1.1 SOFTWARE, AND MERLIN PACING SYSTEM ANALYZER (PSA) MODEL EX3100.