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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.
 
DeviceSLS SPECTRANETICS LASER SHEATHS
Generic NameDEVICE, REMOVAL, PACEMAKER ELECTRODE, PERCUTANEOUS
ApplicantSpectranetics (Philips)
9965 Federal Drive
Colorado Springs, CO 80921
PMA NumberP960042
Supplement NumberS040
Date Received07/02/2012
Decision Date07/31/2012
Product Code MFA 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
CHANGES TO THE ON-DEMAND LABEL PRINTING SYSTEM.
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