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.
 
DeviceSCORPION/SCORPION M ABLATION CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp.
55 TECHNOLOGY DRIVE
LOWELL, MA 01851
PMA NumberP000020
Supplement NumberS010
Date Received06/10/2005
Decision Date02/16/2006
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 THE ADDITION OF A SECOND ARTICULATION TO THE STINGER S/STINGER SM LINE OF RF ABLATION CATHETERS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME SCORPION/SCORPION M, AND IS INDICATED FOR CREATING FOCAL ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCEDURES TO TREAT ARRHYTHMIAS, AND FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND DELIVERING DIAGNOSTIC PACING STIMULI. IN ADDITION, APPROVAL FOR A CHANGE IN THE INDICATIONS FOR USE OF THE TEMPLINK/ TEMPLINK M CONNECTION CABLES TO INCLUDE THE SCORPION/SCORPION M CATHETERS IN THE LIST OF CATHETERS WITH WHICH IT CAN BE USED.
-
-