MINIMED 530G INSULIN PUMP
FDA premarket approval P120010/S036 · decided 2015-02-13
Approval details
- PMA number
- P120010
- Supplement
- S036
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- MINIMED 530G INSULIN PUMP
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic, Inc.
- Date received
- 2014-09-22
- Decision date
- 2015-02-13
- Days to decision
- 144 days
- Decision code
- APPR
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR CHANGES TO THE PUMP MOTOR SINTERED BEARING MATERIAL.
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