Medtronic MiniMed 530G System
FDA premarket approval P120010/S109 · decided 2018-01-19
Approval details
- PMA number
- P120010
- Supplement
- S109
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Medtronic MiniMed 530G System
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic, Inc.
- Date received
- 2017-12-22
- Decision date
- 2018-01-19
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Adding a new ISO Class 8 Cleanroom for the manufacturing of Enlite Sensors and Guardian Sensors at Medtronics Northridge facility. The Enlite sensors are components of the MiniMed 530G, Paradigm Real-Time Revel, and iPro2 CGM systems and the Guardian Sensors are components of the MiniMed 630G and MiniMed 670G systems.
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