• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameBLAZER II XP,BLAZER PRIME XP TEMPERATURE ABLATION CATHETERS
Classification Namecatheter, percutaneous, cardiac ablation, for treatment of atrial flutter
Generic Nameradiofrequency generator/cardiac ablation catheter
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP020025
Supplement NumberS051
Date Received11/21/2013
Decision Date12/18/2013
Product Code
OAD[ Registered Establishments with OAD ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Vendor manufacturing changes for the blazer ii, blazer ii htd, blazer prime htd, blazer ii xp, and blazer prime xp ablation catheters.
-
-