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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)
Classification Namedevice, removal, pacemaker electrode, percutaneous
ApplicantSPECTRANETICS CORP.
PMA NumberP960042
Supplement NumberS029
Date Received05/09/2011
Decision Date01/13/2012
Product Code
MFA[ Registered Establishments with MFA ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located in colorado springs, colorado.
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