MiniMed 530G Insulin Pump
FDA premarket approval P120010/S121 · decided 2018-11-02
Approval details
- PMA number
- P120010
- Supplement
- S121
- 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
- 2018-10-01
- Decision date
- 2018-11-02
- Days to decision
- 32 days
- Decision code
- OK30
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Implementation of a manufacturing aid in assembly of the Paradigm family of insulin pumps. The Paradigm pumps are components of the MiniMed 530G System, Paradigm REAL-Time System, and Paradigm REAL-Time Revel System.
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