Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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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 | S204 |
Date Received | 04/30/2018 |
Decision Date | 05/30/2018 |
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 |
Approval Order Statement Change from a manual to an automated pull test system to decrease variability and increase production capacity for the Paradigm and 530G insulin pumps housing. The Paradigm insulin pumps are components of the Continuous Glucose Monitoring System, Paradigm REAL-Time Revel System, and Paradigm REAL-Time System and the MiniMed 530G pumps are components of the MiniMed 530G System. |
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