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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceSPECTRANETICS LASER SHEATHS (SLS)
ApplicantSpectranetics (Philips)
9965 Federal Drive
Colorado Springs, CO 80921
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 - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
The 135-day supplement requested apprroval for the addition of ethylene oxide sterilization equipment.
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