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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
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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