MiniMed 530G System
FDA premarket approval P120010/S117 · decided 2018-06-28
Approval details
- PMA number
- P120010
- Supplement
- S117
- Supplement type
- Special (Immediate Track)
- 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
- 2018-06-07
- Decision date
- 2018-06-28
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Approval for the addition of two 100% visual inspections to the needle hub assembly used in the Guardian Sensor (3) and Enlite Glucose Sensor. The Guardian Sensor (3) is a component of the MiniMed 630G System with SmartGuard, Guardian Connect System, and MiniMed 670G System. The Enlite Sensor is a component of the MiniMed 530G System, Paradigm Real-Time Revel System, MiniMed 630G System With SmartGuard, and MiniMed iPro2 CGM System with Enlite Sensor.
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