PMA P120005S001

Device: DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S001
Product code: MDS
Decision date: 2013-01-04
Classification: Sensor, Glucose, Invasive
Generic name: Sensor, glucose, invasive
Approval order statement: SEMI-AUTOMATE THE SUB-ASSEMBLY DISPOSABLE SEAL (DS) PROCESS USED IN THE G4 CONTINUOUS GLUCOSE MONITORING SYSTEM. ADDITIONALLY, A NEW CLEAN ROOM WAS ADDED TO ACCOMMODATE THE NEW DISPOSABLE SEAL MACHINE AND PROVIDE ADDITIONAL MANUFACTURING CAPACITY FOR THE OTHER PROCESSES.

Current openFDA PMA Record#

Device: DEXCOM G4 PLATINUM PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P120005
Supplement: S001
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2013-01-04
Decision code: OK30
Date received: 2012-12-05
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: SEMI-AUTOMATE THE SUB-ASSEMBLY DISPOSABLE SEAL (DS) PROCESS USED IN THE G4 CONTINUOUS GLUCOSE MONITORING SYSTEM. ADDITIONALLY, A NEW CLEAN ROOM WAS ADDED TO ACCOMMODATE THE NEW DISPOSABLE SEAL MACHINE AND PROVIDE ADDITIONAL MANUFACTURING CAPACITY FOR THE OTHER PROCESSES.