t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM (t:slim G4 system); t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM

FDA premarket approval P140015/S024 · decided 2018-04-17

Approval details

PMA number

P140015

Supplement

S024

Supplement type

Real-Time Process

Supplement reason

Change Design/Components/Specifications/Material

Trade name

t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM (t:slim G4 system); 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

2018-01-17

Decision date

2018-04-17

Days to decision

90 days

Decision code

APPR

Product code

OYC

Advisory committee

Clinical Chemistry

Expedited review

No

Location

San Diego, CA

Statement

Approval for minor design changes to the pump housing and patient line port of the t:slim X2 Insulin Pump. The t:slim X2 Insulin Pump is a part of the t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System.

510(k) clearances by this applicant