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Device | MINIMED REAL-TIME TRANSMITTER (MMT-7703), CONTINUOUS GLUCOSE MONITORING SYSTEM (CGMS) IPRO DIGITAL RECORDER (MMT-7709) |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S026 |
Date Received | 03/06/2008 |
Decision Date | 04/23/2008 |
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 MODIFICATIONS TO THE MINIMED REAL-TIME TRANSMITTER AND THE CGMS IPRO DIGITAL RECORDER. THE MODIFICATION INCLUDES ADDING AN ESD PROTECTION DIODE AND A FEW OTHER CIRCUIT CHANGES TO THE RF INPUT/OUTPUT PORT OF THE DEVICES. |