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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceSTINGER SM ABLATION CATHETER
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp.
55 TECHNOLOGY DRIVE
LOWELL, MA 01851
PMA NumberP000020
Supplement NumberS004
Date Received08/24/2001
Decision Date10/10/2001
Withdrawal Date 01/12/2024
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF ANOTHER ABLATION CATHETER MODEL TO THE EXISTING STINGER(TM) PRODUCT LINE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME STINGER(TM) SM 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 STIMULI.
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