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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namecardiac ablation percutaneous catheter
Generic Namecardiac ablation percutaneous catheter
Boston Scientific Corp.
150 baytech drive
san jose, CA 95134
PMA NumberP920047
Supplement NumberS023
Date Received04/01/2004
Decision Date05/18/2004
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the expiration date from one-year to three-years.