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 035 Drug Coated Balloon PTA Catheter
Generic NameDrug-coated peripheral transluminal angioplasty catheter
ApplicantLutonix
9409 Science Center Dr.
New Hope, MN 55428
PMA NumberP170003
Supplement NumberS022
Date Received06/24/2021
Decision Date09/07/2021
Product Code PRC 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
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 a shelf-life extension from 12 to 24 months for the 8-9 mm diameter devices and a shelf-life extension from 12 to 36 months for the 7x80 mm and 7x100 mm device sizes.
-
-