ENLITE GLUCOSE SENSOR, ENLITE GLUCOSE SENSOR (MMT-7008)
FDA premarket approval P120010/S021 · decided 2014-07-10
Approval details
- PMA number
- P120010
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ENLITE GLUCOSE SENSOR, ENLITE GLUCOSE SENSOR (MMT-7008)
- Generic name
- Automated insulin dosing , threshold suspend
- Applicant
- Medtronic, Inc.
- Date received
- 2014-04-11
- Decision date
- 2014-07-10
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- OZO
- Advisory committee
- Clinical Chemistry
- Expedited review
- No
- Location
- Northridge, CA
- Statement
- APPROVAL TO LOWER THE PURITY SPECIFICATION LIMIT FOR THE CHROMIUMLAYER ON ENLITE¿ GLUCOSE SENSOR (MMT-7008) OF THE MINIMED 530G SYSTEM AND SOF¿ GLUCOSE SENSOR (MMT-7002, MMT-7003) OF THE PARADIGM REAL-TIME REVEL SYSTEM.
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