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.
 
DeviceLutonix Drug Coated Balloon PTA Catheter
Generic NameDrug-coated peripheral transluminal angioplasty catheter
ApplicantLutonix
9409 Science Center Dr.
New Hope, MN 55428
PMA NumberP170003
Supplement NumberS026
Date Received03/09/2023
Decision Date08/29/2024
Product Code PRC 
Advisory Committee Cardiovascular
Clinical TrialsNCT03506308
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for changes to the labeling of the Lutonix 035 Drug Coated Balloon (DCB) PTA Catheter (Model 9010) and Lutonix 018 DCB PTA Catheter (Model 9014) to include results of the Lutonix Global AV Registry
-
-