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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.
 
Trade NameSPECTRANETICS LASER SHEATH (SLS) CATHETERS
Classification Namedevice, removal, pacemaker electrode, percutaneous
Generic Namedevice, removal, pacemaker electrode, percutaneous
ApplicantSPECTRANETICS CORP.
PMA NumberP960042
Supplement NumberS014
Date Received06/02/2009
Decision Date07/28/2009
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 a change of material used to make the proximal coupler of the catheter. The material will be changed from dow magnum 9555 to sabic cycolac mg47md.
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