• 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 NameRESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM
Classification Namecoronary drug-eluting stent
ApplicantMEDTRONIC IRELAND
PMA NumberP110013
Supplement NumberS009
Date Received03/14/2013
Decision Date04/12/2013
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Type Special Supplement
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for an update to the product labeling to add the acronym 'bms' to the integrity product and 'des' to the resolute integrity product to the device's luer.
-
-