Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: GST (MINILINK TRANSMITTER) & GSR (CGMS I PRO RECORDER)
• Classification Name: sensor, glucose, invasive
• Generic Name: continuous subcutaneous glucose monitoring system
• Applicant: MEDTRONIC MINIMED
• PMA Number: P980022
• Supplement Number: S030
• Date Received: 07/07/2008
• Decision Date: 07/17/2008
• Product Code: MDS [ Registered Establishments with MDS ]
• Advisory Committee: Clinical Chemistry
• Supplement Type: 30-day notice
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Change to eliminate the hit test screening step from the final packaging.