• 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 NameMEDTRONIC MODEL 8472 ISOMED CONSTANT-FLOW PUMP (ISOMED PUMP)
Classification Namepump, infusion, implanted, programmable
Applicant MEDTRONIC INC.
PMA NumberP990034
Supplement NumberS013
Date Received07/09/2009
Decision Date08/06/2009
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an errata insert communicating the incompatibility issue of the sutureless connectors to the model 8472 isomed constant-flow pump.
-
-