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 Revel Insulin Pump |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P150019 |
Supplement Number | S047 |
Date Received | 10/01/2018 |
Decision Date | 11/02/2018 |
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 Implementation of a manufacturing aid in assembly of the Paradigm family of insulin pumps. The Paradigm pumps are components of the MiniMed 530G System, Paradigm REAL-Time System, and Paradigm REAL-Time Revel System. |
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