PMA P050020S031

Device: FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Abbott Laboratories
PMA number: P050020
Supplement: S031
Product code: MDS
Decision date: 2010-11-23
Generic name: Sensor, glucose, invasive
Approval order statement: CHANGE IN THE CLEANING PROCEDURE OF THE REACTORS USED TO MAKE THE NPBI MEDIATOR CHEMICAL USED IN THE FREESTYLE TEST STRIPS AND THE TIME FRAME IN WHICH THIS CLEANING PROCESS TAKES PLACE.

Current openFDA PMA Record

Device: FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM
Applicant: Abbott Laboratories
PMA number: P050020
Supplement: S031
Product code: MDS
Generic name: Sensor, glucose, invasive
Decision date: 2010-11-23
Decision code: OK30
Date received: 2010-10-25
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: CHANGE IN THE CLEANING PROCEDURE OF THE REACTORS USED TO MAKE THE NPBI MEDIATOR CHEMICAL USED IN THE FREESTYLE TEST STRIPS AND THE TIME FRAME IN WHICH THIS CLEANING PROCESS TAKES PLACE.