• 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePARADIGM REAL-TIME SYSTEM
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
Applicant
MEDTRONIC MINIMED
18000 devonshire st
northridge, CA 91325
PMA NumberP980022
Supplement NumberS081
Date Received08/10/2010
Decision Date10/13/2010
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR A SOFTWARE CHANGE TO THE PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS MMT-523, MMT-723, MMT-523K, MMT-723K), VERSION 2.4A.
-
-