Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | Paradigm Real Time Revel System |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P150019 |
Supplement Number | S030 |
Date Received | 05/30/2017 |
Decision Date | 06/23/2017 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Qualification of a second injection molding machine to produce the "Hub Body" component of the Enlite Sensor (MMT-7008). The Enlite Sensor is a component of the MiniMed 530G System, the MiniMed 630G System, the Paradigm Real-Time Revel System, and the iPro2 Continuous Glucose Monitoring System. |
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