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 | ENLITE SENSOR |
Generic Name | Automated insulin dosing , threshold suspend |
Applicant | MEDTRONIC Inc. 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325-1219 |
PMA Number | P120010 |
Supplement Number | S001 |
Date Received | 11/06/2013 |
Decision Date | 10/02/2015 |
Product Code |
OZO |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 135 Review Track For 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDING DUPLICATE EXISTING MANUFACTURING STEPS TO THE PREPARATION OF BULK GLUCOSE OXIDASE (GOX) PERFORMED BY THE SUPPLIER FOR USE IN THE SPONSOR¿S ENLITE SENSOR (MODEL: MMT-7008) AND SOF-SENSOR (MODELS: MMT-7002 AND MMT-7003) DEVICES. THE ENLITE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM. THE SOF-SENSOR IS A COMPONENT OF THE PARADIGM REAL-TIME, PARADIGM REALTIME REVEL, GUARDIAN REAL-TIME, MINILINK REAL-TIME, IPRO RECORDER AND IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEMS. |
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