- Device
- COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S539
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2021-09-17
- Decision code
- APPR
- Date received
- 2021-06-21
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the software modifications to the LATITUDE NXT Remote Patient Management System.