• 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 | Inspections
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 NameMEDTRONIC IMPLANTABLE PROGRAMMABLE INFUSION PUMPS
Classification Namepump, infusion, implanted, programmable
ApplicantMEDTRONIC NEUROMODULATION
PMA NumberP860004
Supplement NumberS202
Date Received01/28/2014
Decision Date02/25/2014
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for device refill kit model 8551to reorder the warnings and precautions according to medical importance, to remove information found in the previously approved instructions for use that is not applicable to model 8551, and to align verbiage with the updated model 856x refill kit instructions for use.
-
-