PMA P140015

Device: t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System
Applicant: Tandem Diabetes Care, Inc.
PMA number: P140015
Supplement: S029
Product code: OYC
Decision date: 2019-12-19
Generic name: Pump, infusion, insulin, to be used with invasive glucose sensor
Approval order statement: Rework process change related to the assembling of the Printed Circuit Board Assembly (PCBA) at a Tandem supplier. The PCBA is a component of the Tandem t:slim X2 Insulin Pump system.

Current openFDA PMA Record#

Device: t:slim X2 Insulin Pump with Dexcom G5 Mobile CGM System
Applicant: Tandem Diabetes Care, Inc.
PMA number: P140015
Supplement: S029
Product code: OYC
Generic name: Pump, infusion, insulin, to be used with invasive glucose sensor
Decision date: 2019-12-19
Decision code: OK30
Date received: 2019-11-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Rework process change related to the assembling of the Printed Circuit Board Assembly (PCBA) at a Tandem supplier. The PCBA is a component of the Tandem t:slim X2 Insulin Pump system.