ENLITE GLUCOSE SENSOR
FDA premarket approval P120010/S025 · decided 2014-07-02
Approval details
- PMA number
- P120010
- Supplement
- S025
- Supplement type
- 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
- 2014-06-03
- Decision date
- 2014-07-02
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- CHANGE IN THE MANUFACTURING PROCESS FOR THE ENLITETM GLUCOSE SENSOR (MODEL NUMBERS: MMT-7008A, MMT-7008B) TO ADD A NEW SENSOR FABRICATION CONFIGURATION TO INCLUDEA 48-UP SENSOR MASK. THE ENLITETM GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.
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