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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.
 
DeviceLASER SHEATH
ApplicantSpectranetics (Philips)
9965 Federal Dr.
Colorado Springs, CO 80921
PMA NumberP960042
Supplement NumberS006
Date Received08/11/2000
Decision Date01/17/2001
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR AN INCREASE IN THE LASER "ON" TIME TO 10 SECONDS AND A DECREASE IN THE LASER "OFF" TIME TO 5 SECONDS. THESE DEVICES ARE INDICATED FOR USE AS AN ADJUNCT TO CONVENTIONAL LEAD EXTRACTION TOOLS IN PATIENTS SUITABLE FOR TRANSVENOUS REMOVAL OF CHRONICALLY IMPLANTED PACING OR DEFIBRILLATOR LEADS CONSTRUCTED WITH SILICONE OR POLYURETHANE OUTER INSULATION.
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