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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 NameN
Classification Namecatheter, coronary, atherectomy
Generic Namepercutaneous coronary thrombectomy catheter
ApplicantPOSSIS MEDICAL, INC.
PMA NumberP980037
Supplement NumberS001
Date Received11/02/1999
Decision Date04/03/2000
Product Code
MCX[ Registered Establishments with MCX ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the model tf140 catheter, a modification to the currently apprved lf140 catheter.
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