Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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) | Registration & Listing | Adverse Events | Recalls | PMA | 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.
 
Trade NameSYNCHROMED EL/SYNCHROMED II/ISOMED PUMPS
Classification Namepump, infusion, implanted, programmable
Applicant MEDTRONIC INC.
PMA NumberP990034
Supplement NumberS020
Date Received09/07/2010
Decision Date10/07/2010
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 Yes
Approval Order Statement 
Approval to update the labeling for these devices to specifically state cephalad migration of catheter fragments as part of the adverse event summaries in the devices¿ information for prescribers manuals and user manuals.
-
-