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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 IMPLANTABLE ACCESS SYSTEM, PORT-A-CATH 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 NumberS012
Date Received10/30/2002
Decision Date12/17/2002
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: 1) the addition of procedural accessories to the port-a-cath epidural system kit, 2) an alternate packaging configuration and 3) change in ethylene oxide residual limits. These added accessories are exactly the same as those described in p900052/s005 for port-a-cath ii epidural low-profile system. The device, as modified, will be marketed under the trade name port-a-cath epidural low profile implantable access system and port-a-cath epidural system kits.
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