PMA P050012S017

Device: THE DEXCOM SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S017
Product code: MDS
Decision date: 2008-12-03
Generic name: Sensor, glucose, invasive
Approval order statement: APPROVAL FOR MODIFICATIONS MADE TO THE RECEIVER SUB-COMPONENT PCBA AND HOUSING; MANUFACTURING PROCESSES OF THE RECEIVER TO ACCOMMODATE A REVISED PCBA; AND OUTSOURCING OF THE ALTERNATIVE RECEIVER MANUFACTURING PROCESS.

Current openFDA PMA Record#

Device: THE DEXCOM SEVEN CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S017
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2008-12-03
Decision code: APPR
Date received: 2008-09-23
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR MODIFICATIONS MADE TO THE RECEIVER SUB-COMPONENT PCBA AND HOUSING; MANUFACTURING PROCESSES OF THE RECEIVER TO ACCOMMODATE A REVISED PCBA; AND OUTSOURCING OF THE ALTERNATIVE RECEIVER MANUFACTURING PROCESS.