|
Device | CONTINUOUS GLUCOSE MONITORING SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S008 |
Date Received | 04/15/2002 |
Decision Date | 09/05/2002 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A MANUFACTURING SITE CHANGE AND A DESIGN MODIFICATION OF THE GLUCOSE SENSOR COMPONENT OF THE CONTINUOUS GLUCOSE MONITORING SYSTEM. |