PMA P120010S015

Device: ENLITE GLUCOSE SENSOR, ENLITE SERTER
Applicant: Medtronic, Inc.
PMA number: P120010
Supplement: S015
Product code: OZO
Decision date: 2014-03-31
Classification: Automated Insulin Dosing , Threshold Suspend
Generic name: Automated insulin dosing , threshold suspend
Approval order statement: CHANGE IN THE MANUFACTURING PROCESS FOR THE ENLITETM GLUCOSE SENSOR (MODEL NUMBERS: MMT-7008A, MMT-7008B) BY ADDING AN ADDITIONAL STEP DURING THE ASSEMBLY PROCEDURE AND AN INSPECTION STEP DURING THE PACKAGING PROCEDURE. THE ENLITETM GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.

Current openFDA PMA Record#

Device: ENLITE GLUCOSE SENSOR, ENLITE SERTER
Applicant: Medtronic, Inc.
PMA number: P120010
Supplement: S015
Product code: OZO
Generic name: Automated insulin dosing , threshold suspend
Decision date: 2014-03-31
Decision code: OK30
Date received: 2014-03-04
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE MANUFACTURING PROCESS FOR THE ENLITETM GLUCOSE SENSOR (MODEL NUMBERS: MMT-7008A, MMT-7008B) BY ADDING AN ADDITIONAL STEP DURING THE ASSEMBLY PROCEDURE AND AN INSPECTION STEP DURING THE PACKAGING PROCEDURE. THE ENLITETM GLUCOSE SENSOR IS A COMPONENT OF THE MINIMED 530G SYSTEM.