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 | Guardian Connect System |
Generic Name | Sensor, glucose, invasive |
Applicant | MEDTRONIC MINIMED 18000 DEVONSHIRE STREET NORTHRIDGE, CA 91325-1219 |
PMA Number | P160007 |
Supplement Number | S031 |
Date Received | 11/27/2019 |
Decision Date | 12/19/2019 |
Product Code |
MDS |
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 Adding a new Chemical Vapor Deposition (CVD) line to increase manufacturing capacity for the Guardian Sensor (3) continuous glucose monitoring sensor. The Guardian Sensor is a component of the Guardian Connect, MiniMed 630G, and MiniMed 670G systems. |
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