MiniMed 530G System
FDA premarket approval P120010/S132 · decided 2019-08-14
Approval details
- PMA number
- P120010
- Supplement
- S132
- 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
- 2019-07-15
- Decision date
- 2019-08-14
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Automation of an inspection method at a contract manufacturer used during the packaging of components for the MiniLink REAL-Time transmitter, Guardian Link Transmitter, Guardian Link (3) Transmitter, Guardian Connect System, and iPro2 Recorder. The MiniLink REAL-Time transmitter is a component of the Minimed 530g System, Paradigm REAL-Time Revel System, and the Paradigm REAL-Time System. The Guardian Link Transmitter is a component of the Minimed 630G Insulin Pump System. The Guardian Link (3) T
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