|
Device | CONTINUOUS GLUCOSE MONITORING SYSTEM |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S091 |
Date Received | 12/14/2010 |
Decision Date | 01/12/2011 |
Product Code |
MDS |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Recalls | CDRH Recalls |
Approval Order Statement MINOR MANUFACTURING CHANGES TO THE SOF-SENSOR GLUCOSE SENSOR MMT-7002. THE CHANGES DO NOT INVOLVE ANY CHANGES TO THE DEVICE DESIGN OR PERFORMANCE SPECIFICATIONS. |