t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM

FDA premarket approval P140015/S020 · decided 2017-08-25

Approval details

PMA number

P140015

Supplement

S020

Supplement type

Panel Track

Supplement reason

Change Design/Components/Specifications/Material

Trade name

t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM

Generic name

Pump, infusion, insulin, to be used with invasive glucose sensor

Applicant

Tandem Diabetes Care, Inc.

Date received

2017-03-01

Decision date

2017-08-25

Days to decision

177 days

Decision code

APPR

Product code

OYC

Advisory committee

Clinical Chemistry

Expedited review

No

Location

San Diego, CA

Statement

Approval for the use of the t:slim X2 Insulin Pump with the Dexcom G5 Mobile CGM and for modifying the indications for use to include pediatric patients ages 6-11 years and replace adjunctive with non-adjunctive CGM use (i.e., replace fingerstick blood glucose testing for diabetes treatment decisions). This device is indicated as follows:The t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM (“t:slim X2 System”) consists of the t:slim X2 Insulin Pump paired with the Dexcom G5 Mobile Sensor and Tra

510(k) clearances by this applicant