|
Device | SEN-SERTER, MODEL: MMT-7500 |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S111 |
Date Received | 02/15/2012 |
Decision Date | 03/14/2012 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LABELING CHANGES FOR THE SEN-SERVER COMPONENT OF THE DEVICE. |