ENLITE GLUCOSE SENSOR
FDA premarket approval P120010/S024 · decided 2015-02-19
Approval details
- PMA number
- P120010
- Supplement
- S024
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENLITE GLUCOSE SENSOR
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic, Inc.
- Date received
- 2014-06-02
- Decision date
- 2015-02-19
- Days to decision
- 262 days
- Decision code
- APPR
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL CHANGES TO THE DESIGN AND MANUFACTURING OF THE NEEDLE FORTHE MEDTRONIC MINIMED 530G SYSTEM ENLITE GLUCOSE SENSOR (MMT-7008A, MMT- 7008B); THE SPECIFICALLY PROPOSED CHANGES WHICH INFLUENCE THE ENLITE NEEDLE TO INTRODUCE A BEVEL AT THE NEEDLE TIP AND INCREASE NEEDLE SHARPNESS.
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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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