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.
 
DeviceBLAZER II TEMPERATURE ABLATION CATHETER, BLAZER II HTD TEMPERATURE ABLATION CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp.
150 BAYTECH DRIVE
SAN JOSE, CA 95134
PMA NumberP920047
Supplement NumberS080
Date Received04/29/2015
Decision Date05/29/2015
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL TO ADD AN ADDITIONAL ADVERSE EVENT TO THE DIRECTIONS FOR USE (DFU) WARNING SECTION.
-
-