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. |
|
Device | T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM |
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 | S018 |
Date Received | 12/23/2016 |
Decision Date | 01/18/2017 |
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 Expand the epoxy curing temperature range used in insulin pump device subassemblies for the t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM System. |
|
|