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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 NameWEBSTER DIAG./ABLATION DEFLECTABLE TIP CATHETER
Classification Namecardiac ablation percutaneous catheter
ApplicantCORDIS WEBSTER, INC.
PMA NumberP950005
Supplement NumberS001
Date Received11/10/1997
Decision Date05/07/1998
Product Code
LPB[ Registered Establishments with LPB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the 6 fr and 7 fr cordis webster diagnostic/ablation deflectable tip catheters - thermistor and non-temperature sensing model and interface cables used with the ep technologies 1000 rf generator.
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