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.
 
DeviceIN.PACT AV Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
Generic NameDrug-coated peripheral transluminal angioplasty catheter
ApplicantMedtronic Vascular, Inc.
3576 Unocal Pl.
Santa Rosa, CA 95403
PMA NumberP190008
Supplement NumberS001
Date Received12/18/2019
Decision Date04/10/2020
Product Code PRC 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval of the revised protocol for the New Enrollment IN.PACT AV Access PAS.
-
-