- Device
- COGNIS, ENERGEN, PUNCTUA, INCEPTA, ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE, MOMENTUM, VIGILIANT - CRT-D Resynchroniza
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S522
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2020-10-22
- Decision code
- APPR
- Date received
- 2020-08-06
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for software changes included in LATITUDE NXT Patient Management System Release 7.0.