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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.
 
DeviceSLS SPECTRANETICS LASER SHEATHS
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 NumberS037
Date Received04/10/2012
Decision Date05/16/2012
Product Code
MFA[ Registered Establishments with MFA ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for qualifying the use of loctite 7701 as a suitable replacement for the discontinued loctite 793.
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