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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.
 
DeviceBARD STINGER ABLATION CATHETERS
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp
55 Technology Dr.
Lowell, MA 01851
PMA NumberP000020
Supplement NumberS003
Date Received07/20/2001
Decision Date08/20/2001
Withdrawal Date01/12/2024
Product Code LPB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN ADDITIONAL "G" CURVE CONFIGURATION AND ADDITIONAL LENGTH OF 85 CENTIMETERS FOR THE STINGER, STINGER M, AND STINGER S ABLATION CATHETERS.
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