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 018 Drug Coated Balloon PTA Catheter (Lutonix 018 DCB)
Generic NameDrug-Eluting Peripheral Transluminal Angioplasty Catheter
ApplicantLUTONIX
9409 SCIENCE CENTER DR
NEW HOPE, MN 55428
PMA NumberP130024
Supplement NumberS030
Date Received09/20/2019
Decision Date12/19/2019
Product Code ONU 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for the addition of a maximum balloon length of 300 mm for the 4, 5 and 6 mm balloon diameter sizes, a new colorant in the base catheter, and an increase in marker band length for the Lutonix 018 Drug Coated Balloon PTA Catheter indicated for use in native superficial femoral or popliteal arteries.
-
-