|
Device | GUARDIAN REAL-TIME MONITOR |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S027 |
Date Received | 05/16/2008 |
Decision Date | 06/16/2008 |
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 | No |
Approval Order Statement CHANGES TO THE MONITOR VIBRATOR MOTOR INCLUDING CONFORMANCE WITH ROHS DIRECTIVE WHICH RESTRICTS THE USE OF HAZARDOUS MATERIALS IN THE MANUFACTURE OF ELECTRICAL AND ELECTRONIC PRODUCTS. |