• 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 XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM, SV
Classification Namecoronary drug-eluting stent
Generic Namecoronary drug-eluting stent
Applicant
ABBOTT VASCULAR
3200 lakeside drive
santa clara, CA 95054
PMA NumberP110019
Supplement NumberS047
Date Received05/22/2013
Decision Date04/23/2014
Product Code
NIQ[ Registered Establishments with NIQ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR AN UPDATE TO THE LABELING FOR THE XIENCE XPEDITION RX (RAPID EXCHANGE) AND OTW (OVER-THE-WIRE) TO CHANGE THE GUIDING CATHETER COMPATIBILITY FOR THE 4.0MM BALLOON DIAMETER SIZES FROM A MINIMUM OF A 6 FRENCH (F) GUIDE CATHETER TO 5F FOR THE 4.0 X 8-33MM SIZES.
-
-