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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 NamePORT-A-CATH EPIDURAL IMPLANTABLE ACCESS SYSTEM
Classification Namecatheter, percutaneous, long term, intraspinal
Generic Nameepidural implantable access system
ApplicantSMITHS MEDICAL MD, INC.
PMA NumberP900052
Supplement NumberS013
Date Received07/26/2006
Decision Date04/05/2007
Product Code
LNY[ Registered Establishments with LNY ]
Advisory Committee General Hospital
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a second operator inspection for outlet tube and insert hole alignment to confirm proper alignment of the outlet tube.
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