Minimed 530G System
FDA premarket approval P120010/S122 · decided 2018-11-14
Approval details
- PMA number
- P120010
- Supplement
- S122
- 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
- 2018-10-15
- Decision date
- 2018-11-14
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Manufacturing facility move at one of Medtronics tier one supplier for the manual needle-hub assembly and one-press serter base component. The one-press serter is a component of the Enlite Sensor and Guardian Sensor (3). The needle-hub assembly component is used in the Medtronic Enlite Sensor and the Guardian Sensor (3). The Enlite Sensor is a component of the Medtronic MiniMed 530G, 630G with SmartGuard, Paradigm Real-Time Revel System and iPro2 Continuous Glucose Monitoring Systems and Guardia
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