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 | MINILINK REAL-TIME SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S119 |
Date Received | 07/12/2012 |
Decision Date | 12/26/2013 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A NEW WATERTIGHT TESTER ACCESSORY DEVICE AS WELL AS LABELINGCHANGES RELATED TO NEW CLEANING AND DISINFECTION PROTOCOLS FOR THE MINILINK TRANSMITTER AND NEW WATERTIGHT TESTER. THE MINILINK TRANSMITTER (MODEL MMT-7703) AND THE WATERTIGHT TESTER (MODEL MMT-7726) ARE COMPONENTS OF THE PARADIGM REAL-TIME REVEL SYSTEM, GUARDIAN REALTIME SYSTEM, AND MINI LINK REAL-TIME SYSTEM. |
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