June 1, 2009

From the News Wire: FDA PMA Updates

The FDA updated the PMA database today with April approvals. Not exactly exciting stuff but what the heck someone may find it interesting.

180-Day FreeStyle Navigator Continuous Glucose Monitoring System Abbott Diabetes Care
Alameda , CA
94502 Approval for a sterilization site located at Nutek Corporation, Hayward, California, to perform sterilization of the Sensor Delivery Unit.
Real-Time FreeStyle Navigator Continuous Glucose Monitoring System, CoPilot Health Management System for FreeStyle Naviator Abbott Diabetes Care
Alameda , CA
94502 Approval for an updated version of the CoPilot Health Management System for FreeStyle Navigator Labeling and help files in the application to add windows Vista as an operating system that the application can be installed on as well as adding the necessary steps to allow the application and device to be used with Vista.
Real-Time Medtronic MiniMed Continuous Glucose Monitoring System, SOF-SENSORS on Phillips Base Models MMT-7002, MMT-7003 Medtronic MiniMed
Northridge , CA
91325 Approval for design changes to the MMT-7002 and MMT-7003 glucose sensors models and a new supplier qualification. The design changes included an increase of the needle tunnel height and base from 0.034" to 0.036" and 0.030" and 0.031", respectively. These changes were intended to reduce the probability of a user having difficulty with removing the needle after sensor insertion. Further, the connector ledge of the senor base was increased from 0.007" to 0.011" to reduce relative rotational motion between the sensor base connector and GST transmitter. Phillips Plastics was also qualified as a new supplier for the glucose sensor bases in this supplement. The qualification included modifications including modifications to the needle guard core pin, a manufacturing tooling device. This device is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace, blood glucose information obtained using a standard home glucose-monitoring devices. This information may allow identification of patterns of glucose level excursions above or below the desired range, facilitating therapy adjustments which may minimize these excursions.

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