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.
 
DeviceEXPRESS2 OTW CORONARY STENT SYSTEM
Generic NameSTENT, CORONARY
ApplicantBOSTON SCIENTIFIC SCIMED, INC.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566
PMA NumberP020009
Supplement NumberS046
Date Received08/28/2008
Decision Date09/26/2008
Withdrawal Date 12/06/2018
Product Code MAF 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE TO THE METHOD THAT IS USED TO CREATE THE PROXIMAL MARKS, THREE WHITE CIRCUMFERENTIAL MARKINGS, LOCATED ON THE SHAFT OF THE CATHETER.
-
-