• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


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.
 
Trade NameMINIMED 530G INSULIN PUMP
Classification Nameartificial pancreas device system, threshold suspend
Generic Nameartificial pancreas device system, threshold suspend
ApplicantMEDTRONIC INC.
PMA NumberP120010
Supplement NumberS033
Date Received08/11/2014
Decision Date10/08/2014
Product Code
OZO[ Registered Establishments with OZO ]
Advisory Committee Clinical Chemistry
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to a supplier¿s production line for a motor part of the paradigm real-time insulin pumps (models mmt-522, mmt-522k, mmt-722, mmt-722k), paradigm real-time revel insulin pumps (models mmt-523, mmt-523k, mmt-723 and mmt-723k) and the minimed 530g insulin pumps (models mmt-551 and mmt-751). The insulin pumps are components of the paradigm real-time continuous glucose monitoring system, paradigm real-time revel continuous glucose monitoring system, and the minimed 530g system respectively.
-
-