ENLITE GLUCOSE SENSOR
FDA premarket approval P120010/S058 · decided 2015-06-09
Approval details
- PMA number
- P120010
- Supplement
- S058
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ENLITE GLUCOSE SENSOR
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic, Inc.
- Date received
- 2015-01-26
- Decision date
- 2015-06-09
- Days to decision
- 134 days
- Decision code
- APPR
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR A CHANGE IN THE PRE-DOSING PROCESS OF THE ENLITE SENSORADHESIVE PATCH. THE ENLITE SENSOR (MMT-7008) IS A COMPONENT OF THE MINIMED 530G SYSTEM.
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510(k) clearances by this applicant
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|---|---|---|
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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