T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

FDA premarket approval P140015 · decided 2015-09-08

Approval details

PMA number

P140015

Trade name

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.

Date received

2014-07-17

Decision date

2015-09-08

Days to decision

418 days

Decision code

APPR

Product code

OYC

Advisory committee

Clinical Chemistry

Expedited review

No

Location

San Diego, CA

Statement

APPROVAL FOR THE T:SLIM G4 INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM (¿T:SLIM G4 SYSTEM¿). THIS DEVICE CONSISTS OF THE T:SLIM G4 INSULIN PUMP PAIRED WITH THE DEXCOM G4 PLATINUM SENSOR AND TRANSMITTER.THE T:SLIM G4 INSULIN PUMP IS INTENDED FOR THE SUBCUTANEOUS DELIVERY OF INSULIN, AT SET AND VARIABLE RATES, FOR THE MANAGEMENT OF DIABETES MELLITUS IN PERSONS REQUIRING INSULIN. THE T:SLIM G4 INSULIN PUMP CAN BE USED SOLELY FOR CONTINUOUS INSULIN DELIVERY AND AS PART OF THE T:SLIM G4 SYSTEM TO RECEIV

510(k) clearances by this applicant