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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 ABLATION SYSTEM
Generic NameCardiac ablation percutaneous catheter
ApplicantBoston Scientific Corp
55 Technology Dr.
Lowell, MA 01851
PMA NumberP000020
Supplement NumberS018
Date Received04/18/2014
Decision Date05/16/2014
Withdrawal Date01/12/2024
Product Code LPB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
ACCEPTANCE TO IMPLEMENT AN ADDITIONAL SUPPLIER TO PERFORM MACHINING OF THE ABLATION CATHETER HANDLE COMPONENTS.
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