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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.
 
Device16F LASER SHEATH ENHANCEMENT MODEL#500-013
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 NumberS007
Date Received07/26/2001
Decision Date01/25/2002
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
Approval Order Statement 
APPROVAL FOR A MODIFICATION TO THE 16F LASER SHEATH KIT.
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