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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 SHEATH (SLS) II AND GLIDELIGHT LASER SHEATH
Classification Namedevice, removal, pacemaker electrode, percutaneous
Generic Namedevice, removal, pacemaker electrode, percutaneous
ApplicantSPECTRANETICS CORP.
PMA NumberP960042
Supplement NumberS042
Date Received10/01/2012
Decision Date10/31/2012
Product Code
MFA[ Registered Establishments with MFA ]
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifying the sls ii and glidelight instruction for use manuals to include a warning and precaution statement and strengthen a warning.
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