ENLITE SENSOR
FDA premarket approval P120010/S002 · decided 2013-12-06
Approval details
- PMA number
- P120010
- Supplement
- S002
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENLITE SENSOR
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic, Inc.
- Date received
- 2013-11-07
- Decision date
- 2013-12-06
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL OF PRODUCT SPECIFICATION REQUIREMENTS FOR THE GLUCOSE OXIDASE MATERIAL USED IN THE SOF-SENSORS (MODELS: MMT-7002 AND MMT-7003) AND THE ENLITE SENSOR (MODEL: MMT-7008).
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510(k) clearances by this applicant
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| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
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