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 TRANSMITTER (MMT-7703), IPRO DIGITAL RECORDER (MMT-7709) AND IPRO2 RECORDER (MMT-7741) |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S100 |
Date Received | 10/28/2011 |
Decision Date | 07/06/2012 |
Product Codes |
MDS OYC |
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 AN INCREASE IN BATTERY LEAD WIRE LENGTH AND TOLERANCES, AND INCREASE WIRE STRIPPING TOLERANCES TO MATCH WITH THE WIRE STRIP TOOL CAPABILITIES AFFECTING THE MINILINK TRANSMITTER (MMT-7703), CGMS IPRO RECORDER (MMT-7709) AND IPRO2 RECORDER (MMT-7741), WHICH ARE COMPONENTS OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, IPRO AND IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEMS. |
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