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 | MINIMED 530G INSULIN PUMP |
Generic Name | automated insulin dosing , threshold suspend |
Applicant |
MEDTRONIC Inc. |
18000 devonshire street |
northridge, CA 91325-1219 |
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PMA Number | P120010 |
Supplement Number | S075 |
Date Received | 11/03/2015 |
Decision Date | 12/03/2015 |
Product Code |
OZO
|
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
USE HARVESTED MOTORS WITH SEPARATED FLEX CABLES IN THE MANUFACTURE OF PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, AND MINIMED 530G INSULIN PUMPS. |
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