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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.
 
DevicePORT-A-CATH EPIDURAL/II EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM
Classification Namecatheter, percutaneous, long term, intraspinal
Generic Namecatheter, percutaneous, long term, intraspinal
Applicant
SMITHS MEDICAL ASD, INC.
1265 grey fox road
st. paul, MN 55112
PMA NumberP900052
Supplement NumberS007
Date Received02/11/1999
Decision Date04/21/1999
Product Code
LNY[ Registered Establishments with LNY ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason postapproval study protocol - ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the postapproval protocol to allow the use of low profile system which was approved on 10/28/98.
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