| 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 SYSTEM |
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| Generic Name | Sensor, glucose, invasive |
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| Applicant | Medtronic Minimed
18000 Devonshire St.
Northridge, CA 91325 |
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| PMA Number | P150019 |
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| Supplement Number | S009 |
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| Date Received | 03/07/2016 |
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| Decision Date | 04/05/2016 |
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| Product Codes |
MDS OYC |
| Advisory Committee |
Clinical Chemistry |
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| Clinical Trials | NCT01464346
|
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| Supplement Type | 30-Day Notice |
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| Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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| Predetermined Change Control Plan Authorized | No |
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| Recalls | CDRH Recalls |
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Approval Order Statement
Relocation of a contract manufacturing facility for printed circuit boards and board stack assemblies used in all Medtronic MiniMed Paradigm Real-Time Revel insulin pumps, Paradigm Real-Time insulin pumps, and MiniMed 530G insulin pumps. The firm is also requesting changes in the manufacturing process sequence as well as updates to mechanical drawings to add vendor name and pump models. The Paradigm Real-Time insulin pumps are a component of the Paradigm Real-Time System, Paradigm Real-Time Revel System, and the Paradigm Real-Time Revel System with Enlite Sensor. The MiniMed 530G insulin pumps are a component of the MiniMed 530G System. |
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