PMA P050012S039

Device: DEXCOM SEVEN AND SEVEN PLUS SYSTEM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S039
Product code: MDS
Decision date: 2012-07-24
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR A PROPOSED CHANGE TO REMOVE REDUNDANT DESTRUCTIVE TESTING FOR BOND STRENGTH OF THREE APPLICATOR COMPONENTS (CANNULA CARRIER, PUSH ROD CARRIER, AND SENSOR NEEDLE CARRIER) OF THE DEVICES.

Current openFDA PMA Record#

Device: DEXCOM SEVEN AND SEVEN PLUS SYSTEM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S039
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2012-07-24
Decision code: APPR
Date received: 2011-08-15
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 REMOVE REDUNDANT DESTRUCTIVE TESTING FOR BOND STRENGTH OF THREE APPLICATOR COMPONENTS (CANNULA CARRIER, PUSH ROD CARRIER, AND SENSOR NEEDLE CARRIER) OF THE DEVICES.