MINIMED 530G SYSTEM
FDA premarket approval P120010/S087 · decided 2016-04-21
Approval details
- PMA number
- P120010
- Supplement
- S087
- 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
- 2016-03-25
- Decision date
- 2016-04-21
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Additional Plasma Cleaning System to increase the cleaning capacity of the Enlite components at Medtronic Puerto Rico Operations Company (MPROC). The Enlite sensor is a component of the MiniMed 530G System and the Paradigm Real-Time Revel System with Enlite Sensor.
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