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Device | PARADIGM REAL-TIME INSULIN PUMP & PARADIGM REAL-TIME REVEL INSULIN PUMP |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S098 |
Date Received | 08/26/2011 |
Decision Date | 09/22/2011 |
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 | No |
Recalls | CDRH Recalls |
Approval Order Statement COMPONENT MANUFACTURING LOCATION CHANGE FOR THE SUPPLIER OF THE VIBRATOR MOTOR USED IN THE MANUFACTURE OF THE PARADIGM REAL-TIME PUMP AND THE PARADIGM REAL-TIME REVEL PUMP. |