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 & Paradigm Real-Time Insulin Pump. |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S193 |
Date Received | 07/26/2016 |
Decision Date | 08/25/2016 |
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 Add a new testing station to conduct a Manual Bolus Time Test (BTT) in the manufacturing process of the Paradigm Real-Time Insulin Pumps, Paradigm Real-Time Revel Pumps, and MiniMed 530G Insulin Pumps. These pumps are components of the Paradigm Real-Time System, Paradigm Real-Time Revel System, and MiniMed 530G System, respectively. The testing station will be added to the manufacturing facility, located at Juncos, Puerto Rico. |
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