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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 LASER SHEATHS (SLS)
ApplicantSPECTRANETICS CORP.
PMA NumberP960042
Supplement NumberS005
Date Received09/28/1999
Decision Date03/17/2000
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 135-day supplement requested apprroval for the addition of ethylene oxide sterilization equipment.
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