|
Device | SOF-SENSOR |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S142 |
Date Received | 11/07/2013 |
Decision Date | 12/06/2013 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF PRODUCT SPECIFICATION REQUIREMENTS FOR THE GLUCOSE OXIDASE MATERIAL USED IN THE SOF-SENSORS (MODELS: MMT-7002 AND MMT-7003) AND THE ENLITE SENSOR (MODEL: MMT-7008). |