PMA P050012S029

Device: DEXCOM SEVEN & SEVEN PLUS SYSTEM
Applicant: Dexcom, Inc.
PMA number: P050012
Supplement: S029
Product code: MDS
Decision date: 2010-08-25
Generic name: Sensor, glucose, invasive
Approval order statement: CHANGE TO REDUCE THE HOLD TIME AFTER ADHESIVE IS APPLIED TO ATTACH THE ADHESIVE PATCH TO THE DISPOSABLE HOUSING FOR 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: S029
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2010-08-25
Decision code: OK30
Date received: 2010-07-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE TO REDUCE THE HOLD TIME AFTER ADHESIVE IS APPLIED TO ATTACH THE ADHESIVE PATCH TO THE DISPOSABLE HOUSING FOR THE SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEMS.