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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, PORT-A-CATH EPIDURAL LOW PROFILE IMPLANTABLE ACCESS SYSTEM
Classification Namecatheter, percutaneous, long term, intraspinal
Generic Nameepidural implantable access system
ApplicantDELTEC, INC.
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 - component
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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