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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 NameSPECTRANETICS CVX-300 EXCIMER LASER SYSTEM & LASER SHEATH 12 FRENCH OUTER SHEATH
ApplicantSPECTRANETICS CORP.
PMA NumberP960042
Supplement NumberS001
Date Received12/12/1997
Decision Date06/16/1998
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 12 french outer sheath. The device is an accessory to the 12 french laser sheath and will be packaged in the 12 french laser sheath kit.
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