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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 Name14FR. AND 16FR. LASER SHEATH KIT AND FISH TAPE
ApplicantSPECTRANETICS CORP.
PMA NumberP960042
Supplement NumberS003
Date Received08/14/1998
Decision Date02/08/1999
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 separately packaged 12 french outer sheaths.
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