PMA P050012S036

Device: DEXCOM SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S036
Product code: MDS
Decision date: 2011-03-02
Generic name: Sensor, glucose, invasive
Approval order statement: ALTERNATE VENDOR AND METHOD OF MANUFACTURE OF THE DISPOSABLE SEAL COMPONENT OF THE APPLICATOR ASSEMBLY OF THE SEVEN AND SEVEN PLUS SYSTEMS. THE PROPOSED CHANGE APPLIES ONLY TO THE DISPOSABLE SEAL SUPPLIER AND THE METHOD OF MANUFACTURE; NEITHER THE MATERIALS NOR THE FINAL DESIGN OF THE DISPOSABLE SEAL ARE ALTERED. SENSOR PERFORMANCE AND RELEASE SPECIFICATION WILL ALSO REMAIN UNCHANGED.

Current openFDA PMA Record#

Device: DEXCOM SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S036
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2011-03-02
Decision code: OK30
Date received: 2011-01-31
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: ALTERNATE VENDOR AND METHOD OF MANUFACTURE OF THE DISPOSABLE SEAL COMPONENT OF THE APPLICATOR ASSEMBLY OF THE SEVEN AND SEVEN PLUS SYSTEMS. THE PROPOSED CHANGE APPLIES ONLY TO THE DISPOSABLE SEAL SUPPLIER AND THE METHOD OF MANUFACTURE; NEITHER THE MATERIALS NOR THE FINAL DESIGN OF THE DISPOSABLE SEAL ARE ALTERED. SENSOR PERFORMANCE AND RELEASE SPECIFICATION WILL ALSO REMAIN UNCHANGED.