MiniMed 530G System
FDA premarket approval P120010/S126 · decided 2018-12-07
Approval details
- PMA number
- P120010
- Supplement
- S126
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MiniMed 530G System
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic, Inc.
- Date received
- 2018-11-07
- Decision date
- 2018-12-07
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Introduce an alternative probe module and manufacturing process for Enlite sensor encapsulation. The Enlite sensor is a component of the MiniMed 530G System, the MiniMed 630G System with SmartGuard, the MiniMed Paradigm Real-Time Revel System, and the MiniMed iPro2 CGM System with Enlite Sensor.
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