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.
 
DeviceMISAGO RX self-expanding Peripheral stent
Generic NameSTENT, SUPERFICIAL FEMORAL ARTERY
ApplicantTerumo Medical Corporation
950 Elkton Blvd.
Hatagaya 151-0072
PMA NumberP140002
Supplement NumberS018
Date Received10/12/2018
Decision Date11/09/2018
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  
Minor changes to the packaging process for the sterile barrier system of the MISAGO RX Self-expanding Peripheral Stent ("MISAGO") System.
-
-