- Device
- SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS
- Applicant
- St. Jude Medical, Inc.
- PMA number
- P880006
- Supplement
- S088
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2014-05-29
- Decision code
- APPR
- Date received
- 2014-04-15
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE MODEL 3330 VERSION 18.1.1 SOFTWARE FOR THE MERLIN PATIENT CARE SYSTEM PROGRAMMER MODEL 3650.