|
Device | STINGER(TM) AND STINGER S(TM) ABLATION CATHETER AND TEMPLINK(TM) EXTENSION CABLE |
Generic Name | Cardiac ablation percutaneous catheter |
Applicant | Boston Scientific Corp. 55 TECHNOLOGY DRIVE LOWELL, MA 01851 |
PMA Number | P000020 |
Supplement Number | S001 |
Date Received | 01/08/2001 |
Decision Date | 05/18/2001 |
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 A CHANGE TO THE MATERIALS OF THE CATHETER TIP TO INCREASE ITS STIFFNESS AND OTHER MINOR DEVICE MODIFICATIONS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STIN S ABLATION CATHETER 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. |