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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(TM) M ABLATION CATHETER/TEMPLINK(TM) M EXTENSION CABLE
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp
55 Technology Dr.
Lowell, MA 01851
PMA NumberP000020
Supplement NumberS002
Date Received01/09/2001
Decision Date02/07/2001
Withdrawal Date01/12/2024
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE STINGER M ABLATION CATHETER (MODELS 210001M - 210006M) AND THE TEMPLINK M CABLE (MODEL 210078M). THE DEVICES ARE INDICATED FOR CREATING FOCAL ENDOCARDIAL LESIONS DURING CARDIAC ABLATION PROCDURES TO TREAT ARRHYTHMIAS AND FOR CARDIAC ELECTROPHYSIOLOGICAL MAPPING AND DELIVERING DIAGNOSTIC PACING STIMULI.
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