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. |
|
Device | SCORPION/SCORPION M ABLATION CATHETER |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 55 TECHNOLOGY DRIVE LOWELL, MA 01851 |
PMA Number | P000020 |
Supplement Number | S010 |
Date Received | 06/10/2005 |
Decision Date | 02/16/2006 |
Withdrawal Date
|
01/12/2024 |
Product Code |
LPB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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. |
|
|