PMA P880006S085
- Device
- SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S085
- Product code
- NIK
- Decision date
- 2014-03-20
- 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
- SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S085
- 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.