• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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.
 
DeviceMINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
Applicant
MEDTRONIC MINIMED
18000 devonshire st
northridge, CA 91325
PMA NumberP980022
Supplement NumberS110
Date Received02/09/2012
Decision Date07/17/2012
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for language and pictorial changes to the instructions foruse (ifu) of the sof-sensor glucose sensor (mmt-7002) to make it consistent with the language that is included in the currently approved paradigm real-time revel insulin pump and paradigm real-time insulin pump user guides. The sof-sensor, paradigm real-time revel insulin pump and paradigm real-time insulin pump are components of the paradigm real- time system, guardian real-time system, and ipro2 professional continuous glucosemonitoring (cgm) system.
-
-