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.
 
DeviceINTRACOIL PERIPHERAL STENT
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantMedtronic Vascular, Inc.
3033 Campus Dr.
Plymouth, MN 55441
PMA NumberP000033
Supplement NumberS001
Date Received01/16/2004
Decision Date02/13/2004
Withdrawal Date03/30/2018
Product Code NIP 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE MANUFACTURING PROCESS TO PROPOSE AN ALTERNATE WIRE POLISHING VENDOR FOR THE NITINOL WIRE POLISHING PROCESS.
-
-