Smart Monitor, Smart Spot, SmartView Monitor, SmartView HotSpot
FDA premarket approval P950029/S129 · decided 2021-08-13
Approval details
- PMA number
- P950029
- Supplement
- S129
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Smart Monitor, Smart Spot, SmartView Monitor, SmartView HotSpot
- Generic name
- implantable pacemaker Pulse-generator
- Applicant
- MicroPort CRM USA, Inc.
- Date received
- 2020-09-30
- Decision date
- 2021-08-13
- Days to decision
- 317 days
- Decision code
- APPR
- Product code
- DXY
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Arlington, TN
- Statement
- Approval for the creation of new models of home monitors (Smart Monitor, Smart Spot) which will upgrade the modems and replace obsolete components.
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