PMA P050012S033

Device: DEXCOM SEVEN & SEVEN PLUS SYSTEM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S033
Product code: MDS
Decision date: 2011-05-19
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR A PROPOSED CHANGE TO ELIMINATE REDUNDANT POST-WINDING AND POST-SECOND-PARYLENE VISUAL INSPECTION FOR THE SENSOR COMPONENT OF THE SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM.

Current openFDA PMA Record#

Device: DEXCOM SEVEN & SEVEN PLUS SYSTEM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S033
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2011-05-19
Decision code: APPR
Date received: 2010-11-12
Supplement type: 135 Review Track For 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: APPROVAL FOR A PROPOSED CHANGE TO ELIMINATE REDUNDANT POST-WINDING AND POST-SECOND-PARYLENE VISUAL INSPECTION FOR THE SENSOR COMPONENT OF THE SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM.