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.
 
DeviceFreezor Cardiac Cryoablation Catheter
Generic NameCardiac ablation percutaneous catheter
ApplicantMedtronic CryoCath LP
8200 CORAL SEA STREET
MOUNDS VIEW, MN 55112
PMA NumberP020045
Supplement NumberS092
Date Received12/19/2019
Decision Date03/02/2020
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for an alternate manufacturing site (Medtronic Mexico, Tijuana Baja California, Mexico), as well as a new sterilization site (Midwestern Sterilization, Jackson, Missouri)and packaging improvements for Coaxial umbilical component of the CryoAblation System.
-
-