- Device
- Smart Monitor, Smart Spot, SmartView Monitor, SmartView HotSpot
- Applicant
- MicroPort CRM USA, Inc.
- PMA number
- P060027
- Supplement
- S105
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2021-08-13
- Decision code
- APPR
- Date received
- 2020-09-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for the creation of new models of home monitors (Smart Monitor, Smart Spot) which will upgrade the modems and replace obsolete components.