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 670G Pump |
Generic Name | Automated insulin dosing device system, single hormonal control |
Applicant | MEDTRONIC MINIMED, INC. 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325 |
PMA Number | P160017 |
Supplement Number | S012 |
Date Received | 04/10/2017 |
Decision Date | 05/10/2017 |
Product Code |
OZP |
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 Transfer equipment used for leak testing seals of the Paradigm insulin infusion pumps and Next Generation insulin infusion pumps from Medtronic MiniMed to a sub-tier supplier, as well as transferring the task of performing such testing to the sub-tier supplier. The Paradigm insulin infusion pump is component of the Paradigm REAL-Time System, the Paradigm REAL-Time Revel System, and the MiniMed 530G System. The Next Generation insulin infusion pump is a component of the MiniMed 630G System and the MiniMed 670G System. |
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