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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 AND PORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM
Classification Namecatheter, percutaneous, long term, intraspinal
Generic Nameepidural implantable access system
ApplicantSMITHS MEDICAL MD, INC.
PMA NumberP900052
Supplement NumberS016
Date Received08/11/2008
Decision Date04/20/2009
Product Code
LNY[ Registered Establishments with LNY ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a label claim ¿does not contain natural rubber latex. ¿.
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