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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 NumberS037
Date Received04/10/2012
Decision Date05/16/2012
Product Code MFA 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR QUALIFYING THE USE OF LOCTITE 7701 AS A SUITABLE REPLACEMENT FOR THE DISCONTINUED LOCTITE 793.
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