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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.
 
Trade NameBIOSENSE WEBSTER TEMPERATURE CABLES
Classification Namecatheter, electrode recording, or probe, electrode recording
Generic Nametemperature cable
Regulation Number870.1220
ApplicantCORDIS WEBSTER, INC.
PMA NumberP950005
Supplement NumberS008
Date Received04/19/2000
Decision Date05/30/2000
Product Code
DRF[ Registered Establishments with DRF ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate manufacturing facility locarted at biosense webster, inc. , cordis de mexico, chihuahua, mexico.
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