MiniMed 530G Insulin Pump
FDA premarket approval P120010/S120 · decided 2018-08-14
Approval details
- PMA number
- P120010
- Supplement
- S120
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- MiniMed 530G Insulin Pump
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic, Inc.
- Date received
- 2018-07-16
- Decision date
- 2018-08-14
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Addition of a new testing station to conduct additional reliability testing for the pump case of the Paradigm Real-Time Insulin Pumps, Paradigm Real-Time Revel Pumps, and MiniMed 530G Insulin Pumps at the manufacturing facility, located at Juncos, Puerto Rico. These pumps are components of the Paradigm Real-Time System, Paradigm Real-Time Revel System, and MiniMed 530G System, respectively.
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