|
Device | PARADIGM REAL-TIME INSULIN PUMP |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S041 |
Date Received | 11/24/2008 |
Decision Date | 01/30/2009 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR A DESIGN MODIFICATION TO THE PARADIGM REAL-TIME INSULIN PUMP (MMT-551 AND MMT-722) TO CHANGE THE KEYPAD OVERLAY COLORS TO MATCH THE EXISTING COLOR OF THE PUMP CASE AND TO ADD A NEW CASE COLOR WITH MATCHING KEYPAD OVERLAY. |