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 | Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert |
Generic Name | Continuous glucose monitor, implanted, adjunctive use |
Applicant | Senseonics, Incorporated 20451 Seneca Meadows Parkway Germantown, MD 20876-7005 |
PMA Number | P160048 |
Supplement Number | S027 |
Date Received | 01/23/2024 |
Decision Date | 02/22/2024 |
Product Code |
QCD |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement to modify the Insertion Tools’s sterilization cycle parameters. The Insertion Tools are components of the Eversense E3 Continuous Glucose Monitoring System |
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