ENLITE SENSOR
FDA premarket approval P120010/S030 · decided 2015-02-04
Approval details
- PMA number
- P120010
- Supplement
- S030
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENLITE SENSOR
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic, Inc.
- Date received
- 2014-07-07
- Decision date
- 2015-02-04
- Days to decision
- 212 days
- Decision code
- APPR
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR CHANGES TO THE SENSOR BASE WHICH INCLUDED; THE ADDITION OF ANTI-ROTATION PINS AND SNAP ARMS, MODIFICATION OF THE O-RING GLAND; WIDTH, POSITION, AND DIAMETER, AN INCREASE TO THE BORE SIZE AND ADDITION OF A BORE TAPER, A SENSOR THROUGH-HOLE SIZE INCREASE, AND CONNECTOR PAD SURFACE HEIGHT INCREASE, ON THE ENLITETM GLUCOSE SENSOR (MMT-7008) OF THE MINIMED 530G SYSTEM.
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510(k) clearances by this applicant
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|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
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| Clearview Intracoronary Shunts (K253998) | Medtronic, Inc. | 2026-01-20 |
| Bio-Medicus Life Support Catheter and Introducer (K251831) | Medtronic, Inc. | 2026-01-15 |
| Concerto Versa™ Detachable Coil (K253511) | Medtronic, Inc. | 2026-01-14 |
| C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) (K253409) | Medtronic, Inc. | 2025-12-19 |