Medtronic MiniMed 530G System
FDA premarket approval P120010/S115 · decided 2018-05-23
Approval details
- PMA number
- P120010
- Supplement
- S115
- 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
- 2018-03-26
- Decision date
- 2018-05-23
- Days to decision
- 58 days
- Decision code
- OK30
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Addition of contamination controls at a supplier during manufacturing of liquid glucose oxidase. The glucose oxidase is used in production of Enlite and Guardian glucose sensors.
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