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 | MEDTRONIC MINIMED CONTINUOUS SUBCUTANEOUS GLUCOSE MONITORING SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S128 |
Date Received | 11/14/2012 |
Decision Date | 02/11/2013 |
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 |
Approval Order Statement APPROVAL FOR A CHANGE TO THE PACKAGING OF A LOW DROPOUT (LDO)REGULATOR INTEGRATED CIRCUIT TO HALOGEN FREE AND A CHANGE OF THE SOLDER PLATING TO PURE TIN SOLDER PLATING FOR THE MINILINK REAL-TIME TRANSMITTER (MMT-7703), CGMS IPRO RECORDER (MMT- 7709), AND IPRO2 RECORDER (MMT-7741) COMPONENTS OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, CGMS IPRO, AND IPRO2 PROFESSIONAL GLUCOSE MONITORING SYSTEMS. |
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