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) AND CGMS IPRO RECORDER (MMT-7709) |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S115 |
Date Received | 03/08/2012 |
Decision Date | 04/26/2012 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE FROM A SINGLE CAVITY INJECTION MOLD TO A TWO CAVITYINJECTION MOLD FOR THE MANUFACTURE OF THE CONNECTOR HOUSING AND CONTACT COMPONENTS OF THE MINILINK TRANSMITTER (MMT-7703) AND IPRO DIGITAL RECORDER (MMT-7709). THE MINILINK TRANSMITTER AND IPRO DIGITAL RECORDER ARE COMPONENTS OF PARADIGM REAL-TIME, GUARDIANREAL-TIME AND IPRO CONTINUOUS GLUCOSE MONITORING SYSTEMS. |
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