PMA P050012S021

Device: DEXCON SEVEN SENSOR
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S021
Product code: MDS
Decision date: 2009-12-04
Generic name: Sensor, glucose, invasive
Approval order statement: REPLACEMENT OF PAPER-BASED LOT HISTORY RECORDS (LHRS) WITH ELECTRONIC LHRS. THE CHANGE IMPLEMENTS CAMSTAR MANUFACTURING EXECUTION SYSTEM (MES), AN ELECTRONIC CONTROL SYSTEM FOR MANAGING AND MONITORING WORK-IN PROCESS ON A MANUFACTURING FLOOR.

Current openFDA PMA Record#

Device: DEXCON SEVEN SENSOR
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S021
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2009-12-04
Decision code: OK30
Date received: 2009-11-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: REPLACEMENT OF PAPER-BASED LOT HISTORY RECORDS (LHRS) WITH ELECTRONIC LHRS. THE CHANGE IMPLEMENTS CAMSTAR MANUFACTURING EXECUTION SYSTEM (MES), AN ELECTRONIC CONTROL SYSTEM FOR MANAGING AND MONITORING WORK-IN PROCESS ON A MANUFACTURING FLOOR.