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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
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 NumberS043
Date Received11/07/2012
Decision Date06/14/2013
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 A MATERIAL CHANGE TO THE INNER LINER OF THE DEVICES.
Approval Order Approval Order
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