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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.
 
DeviceSMART CONTROL VASCULAR STENT SYSTEMS
Classification Namestent, superficial femoral artery
Generic Namestent, superficial femoral artery
Applicant
CORDIS CORP.
6500 paseo padre parkway
fremont, CA 94555
PMA NumberP120002
Supplement NumberS004
Date Received05/12/2014
Decision Date06/13/2014
Product Code
NIP[ Registered Establishments with NIP ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of a new ultrasonic welder to be used by the supplier of the hemostasis valve of the slider assembly.
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