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Device | MEDTRONIC PARADIGM CONTINUOUS GLUCOSE MONITORING SYSTEMS |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S097 |
Date Received | 04/22/2011 |
Decision Date | 05/20/2011 |
Product Codes |
MDS OYC |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement INCLUSION OF AN ALTERNATE SUPPLIER FOR THE CASE ASSEMBLY USED IN THE MANUFACTURE OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL INSULIN PUMPS. |