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 | SOF-SENSOR |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S159 |
Date Received | 07/11/2014 |
Decision Date | 11/12/2015 |
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 |
Approval Order Statement APPROVAL FOR AN INCOMING RECEIVING MATERIAL SPECIFICATION CHANGE OF A CRITICAL DEVICE COMPONENT (GOX) USED IN THE SENSOR FABRICATION PROCESS FOR THE ENLITE SENSOR (MMT-7008) AND SOF-SENSOR (MMT-7002, MMT-7003). THESE SENSORS ARE COMPONENTS OF THE MINIMED 530G SYSTEM AND PARADIGM REAL-TIME SYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, GUARDIAN REAL-TIME CGM SYSTEM, MINILINK REAL-TIME SYSTEM, IPRO RECORDER CGM SYSTEM, AND IPRO2 PROFESSIONAL CGM SYSTEM, RESPECTIVELY. |
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