T:SLIM G4TM INSULIN PUMP WITH DEXCOM G4 PLATINUM CGM

FDA premarket approval P140015/S010 · decided 2016-07-20

Approval details

PMA number

P140015

Supplement

S010

Supplement type

30-Day Notice

Supplement reason

Process Change - Manufacturer/Sterilizer/Packager/Supplier

Trade name

T:SLIM G4TM 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

2016-06-23

Decision date

2016-07-20

Days to decision

27 days

Decision code

OK30

Product code

OYC

Advisory committee

Clinical Chemistry

Expedited review

No

Location

San Diego, CA

Statement

Automate the software loading process performed during manufacture of the t:slim G4 Insulin Pump at the Tandem Diabetes Care manufacturing plant in San Diego, CA. The t:slim G4 Insulin Pump is a component of the Dexcom G4 Platinum CGM System. The proposed change does not alter the device design, materials, or performance specifications. The change does not affect the labeling of the device.

510(k) clearances by this applicant