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Device | MINILINK REAL-TIME TRANSMITTER (MMT-7703) |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S120 |
Date Received | 08/03/2012 |
Decision Date | 08/17/2012 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement TRANSFER OF THE SUB-ASSEMBLY MANUFACTURING PROCESSES OF THE MINILINK REAL-TIME TRANSMITTER (MMT-7703) FROM INTRICON CORPORATION IN ARDEN HILLS, MINNESOTA TO ANALTERNATE MANUFACTURING FACILITY AT INTRICON IN ADMIRAX, SINGAPORE. THE MINILINK REAL-TIME TRANSMITTER IS A COMPONENT OF THE DEVICES. |