MINIMED 530G SYSTEM
FDA premarket approval P120010/S100 · decided 2017-03-27
Approval details
- PMA number
- P120010
- Supplement
- S100
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- MINIMED 530G SYSTEM
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic, Inc.
- Date received
- 2016-12-23
- Decision date
- 2017-03-27
- Days to decision
- 94 days
- Decision code
- APPR
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- Approval for revisions to patient labeling to include instructions for how users should apply a second Enlite Overtape over the Enlite Sensor.
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510(k) clearances by this applicant
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|---|---|---|
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