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. |
|
Device | PARADIGM REAL-TIME INSULIN PUMP |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE ST NORTHRIDGE, CA 91325 |
PMA Number | P980022 |
Supplement Number | S163 |
Date Received | 10/20/2014 |
Decision Date | 11/19/2014 |
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 ADDITION OF EQUIPMENT USED IN THE MANUFACTURE OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, AND MINIMED 530G INSULIN PUMPS THAT ARE PART OF THE PARADIGM REAL-TIME SYSTEM, THE PARADIGM REAL-TIME REVEL SYSTEM, AND THE MINIMED 530G SYSTEM. |
|
|