PMA P050012S043

Device: DEXCOM SEVEN & SEVEN PLUS SYSTEM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S043
Product code: MDS
Decision date: 2012-01-18
Generic name: Sensor, glucose, invasive
Approval order statement: CHANGE IN A MANUFACTURING FIXTURE USED IN THE ATTACHMENT OF AN ADHESIVE PATCH IN THE SENSOR/APPLICATOR DELIVERY SYSTEM COMPONENT IN THE SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEMS. ADDITIONALLY, THE MECHANICAL INSTRON PULL TEST WAS REPLACED WITH A MANUAL ADHESIVE PATCH PULL TEST TO BE USED IN RECEIVING INSPECTION FOR THE DISPOSABLE HOUSING OF THE SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEMS.

Current openFDA PMA Record#

Device: DEXCOM SEVEN & SEVEN PLUS SYSTEM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S043
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2012-01-18
Decision code: OK30
Date received: 2011-12-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN A MANUFACTURING FIXTURE USED IN THE ATTACHMENT OF AN ADHESIVE PATCH IN THE SENSOR/APPLICATOR DELIVERY SYSTEM COMPONENT IN THE SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEMS. ADDITIONALLY, THE MECHANICAL INSTRON PULL TEST WAS REPLACED WITH A MANUAL ADHESIVE PATCH PULL TEST TO BE USED IN RECEIVING INSPECTION FOR THE DISPOSABLE HOUSING OF THE SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEMS.