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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, STINGER S, SCORPION, SCORPION *2 ABLATION CATHETERS AND TEMPLINK EXTENSION CABLES
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp
55 Technology Dr.
Lowell, MA 01851
PMA NumberP000020
Supplement NumberS012
Date Received03/31/2009
Decision Date04/21/2009
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 USE OF THE STINGER, STINGER S, SCORPION, SCORPION *2 ABLATION CATHETERS WITH THE BOSTON SCIENTIFIC MAESTRO 3000, EPT-1000XP, AND IRVINE BIOMEDICAL IBI-1500 T9 AND IBI-150 T6 RF GENERATORS.
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