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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.
 
DeviceSPECTRANETICS LASER SHEATHS SLS
Classification Namedevice, removal, pacemaker electrode, percutaneous
Generic Namedevice, removal, pacemaker electrode, percutaneous
Applicant
SPECTRANETICS CORP.
96 talamine ct.
colorado springs, CO 80907-5159
PMA NumberP960042
Supplement NumberS045
Date Received11/27/2012
Decision Date12/26/2012
Product Code
MFA[ Registered Establishments with MFA ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Addition of a new computer numeric control (cnc) machining tool.
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