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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.
 
DeviceSPECTRANETICS LASER SHEATH DEVICE
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 NumberS031
Date Received09/06/2011
Decision Date04/20/2012
Product Code
MFA[ Registered Establishments with MFA ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Review Memo Review Memo
Approval Order Statement 
APPROVAL FOR AN INCREASE IN THE MAXIMUM REPETITION RATE FROM 40 HZ TO 80 HZ OF THE SPECTRANETICS LASER SHEATH. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GLIDELIGHT LASER SHEATH.
Approval Order Approval Order
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