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 | G4 Insulin Pump with Dexcom G4 Platinum CGM System |
Generic Name | Pump, infusion, insulin, to be used with invasive glucose sensor |
Applicant | Tandem Diabetes Care, Inc. 11045 Roselle Street San Diego, CA 92121 |
PMA Number | P140015 |
Supplement Number | S022 |
Date Received | 05/16/2017 |
Decision Date | 06/15/2017 |
Product Codes |
MDS OYC |
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 Modification to add a QC Manufacturing Aid to complement Quality Control acceptance review during the manufacturing of the t:slim G4 insulin pump, intended to be used with Dexcom G4 Continuous Glucose Monitoring (CGM) sensor and transmitter. |
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