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) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | 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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceXIENCE PRIME EVEROLIMUS ELUTING CORONARY STENT SYSTEM, XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Generic NameCoronary drug-eluting stent
ApplicantABBOTT VASCULAR
3200 Lakeside Drive
Santa Clara, CA 95054
PMA NumberP110019
Supplement NumberS048
Date Received06/28/2013
Decision Date06/02/2014
Product Code NIQ 
Advisory Committee Cardiovascular
Clinical TrialsNCT00916370
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL TO MODIFY THE IN VITRO DRUG RELEASE SPECIFICATIONS FOR THE DEVICES.
Post-Approval StudyShow Report Schedule and Study Progress
-
-