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 | Real-Time REVEL System |
Generic Name | sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 devonshire st northridge, CA 91325 |
PMA Number | P150019 |
Supplement Number | S053 |
Date Received | 02/01/2019 |
Decision Date | 03/13/2019 |
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 Additional injection molding equipment at a contract manufacturer in order to increase production capacity for the Guardian Sensor (3) and Enlite Sensor. The Guardian Sensor (3) is a component of the MiniMed 670G, the Guardian Connect, and the MiniMed 630G System. The Enlite Sensor is a component of the MiniMed iPro 2, MiniMed Paradigm Real-Time Revel, MiniMed 530G, and MiniMed 630G Systems. |
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