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FDA PMA Number P120005, DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
FDA PMA Number P120005, DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
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Request: Device Description and Summary of Studies of the supplement S016 to the PMA number P040003 of the Insightec Exablate system
PMA Number: P120005
Device: DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
Generic Name: Sensor, glucose, invasive
Manufacturer: DEXCOM, INC.
Product Code: MDS
Date Received: 04/09/2012
Decision Date: 10/05/2012
Notice Date: 10/12/2012
PMA Number: P120005
Device: DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
Generic Name: Sensor, glucose, invasive
Manufacturer: DEXCOM, INC.
Product Code: MDS
Date Received: 04/09/2012
Decision Date: 10/05/2012
Notice Date: 10/12/2012
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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