June 15, 2009

From The News Wire: FDA PMA Upates May

The FDA released May PMA Approvals
The following maybe reliant to YDMV readers, DexCom software revisions, Abbott Navigator modifications to the inserter and Mini Med's sensor base and software.

P050012/S018 5/5/09 Real-Time
DexCom Seven Systems
DexCom, Inc.San Diego, CA92121
Approval for design revisions to the accessory software program to provide additional supplementary information to users on glucose trends and patterns downloaded to the program. The software program, as modified, will be marketed under the trade name DexCom Data Manager 3 (DM3) and is indicated for use by consumers to allow for the transfer of glucose data stored by the DexCom STS or Seven Systems into a personal computer (PC). The software modifications included several new features as identified in the submission.

P050020/S012 5/8/09 Real-Time
FreeStyle Navigator Continuous Glucose Monitoring System
Abbott Diabetes Care, Inc.Alameda, CA94502
Approval for modifications to the Inserter component housing of the FreeStyle CGMS, to reduce the overall thickness in the shelves of the housing and a change to the manufacturing equipment used to mold the housing components.

P980022/S054 5/22/09
SOF-SENSOR Glucose Sensor
Medtronic MiniMedNorthridge, CA91325
Changes to the sensor base and the needle/hub components.

P980022/S052 5/22/09 Real-Time
CareLink Pro PC Software
Medtronic MiniMedNorthridge, CA91325
Approval for a modification to the CareLink Pro PC Software (Version 1.3A, MMT-7335) to correct two identified problems.