PMA P000020S010

Device: SCORPION/SCORPION M ABLATION CATHETER
Applicant: Boston Scientific Corp
Product code: LPB
Decision date: 2006-02-16
Generic name: Cardiac ablation percutaneous catheter
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.

Current openFDA PMA Record#

Device: SCORPION/SCORPION M ABLATION CATHETER
Applicant: Boston Scientific Corp
PMA number: P000020
Supplement: S010
Product code: LPB
Generic name: Cardiac ablation percutaneous catheter
Decision date: 2006-02-16
Decision code: APPR
Date received: 2005-06-10
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
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.