• 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 NameXIENCE PRIME/XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEMS
Classification Namecoronary drug-eluting stent
ApplicantABBOTT VASCULAR-CARDIAC THERAPIES
PMA NumberP110019
Supplement NumberS067
Date Received04/14/2014
Decision Date05/13/2014
Product Code
NIQ
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Addition of receiving inspection and testing activities of raw materials and supply items at the clonmel, ireland facility and contract laboratories.
-
-