ENLITE GLUCOSE SENSORS
FDA premarket approval P120010/S041 · decided 2015-01-28
Approval details
- PMA number
- P120010
- Supplement
- S041
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENLITE GLUCOSE SENSORS
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic, Inc.
- Date received
- 2014-10-30
- Decision date
- 2015-01-28
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL FOR MINOR DESIGN CHANGES TO THE SENSOR BASE, O-RING, TAPE, ADHESIVE AND SENSOR PATCH OF THE ENLITE GLUCOSE SENSOR (MMT-7008A, MMT-7008B) IN ORDER TO SUPPORT MANUFACTURING CHANGES FROM A MANUAL ASSEMBLY PROCESS TO AN AUTOMATED ASSEMBLY LINE FOR THE ENLITE GLUCOSE SENSOR. THE ENLITE GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530GSYSTEM.
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