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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 Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Boston Scientific Corp.
100 boston scientific way
marlborough, MA 01752
PMA NumberP000043
Supplement NumberS003
Date Received05/20/2002
Decision Date06/25/2002
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason express gmp supplement
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional manufacturing facility located at tricor systems, inc. , elgin , illinois. The tmx-2000 control system will be manufactured at this facility.