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 | CGMS IPRO SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S028 |
Date Received | 05/19/2008 |
Decision Date | 07/17/2008 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE MMT-7319 SOLUTIONS SOFTWARE FOR CGMS IPRO CONTINUOUS GLUCOSE RECORDER TO DOWNLOAD BLOOD GLUCOSE METER VALUES, OR MANUAL ENTRY OF BLOOD GLUCOSE VALUES, FROM THE LIFESCAN ULTRA 2 AND LIFESCAN ULTRALINK METERS, IN ADDITION TO THE PARADIGM LINK, LIFESCAN ULTRA AND FREESTYLE FLASH METERS. |
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