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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 & PORT-A-CATH II LOW PROFILE EPIDURAL SYSTEMS
Classification Namecatheter, percutaneous, long term, intraspinal
Generic Nameepidural implantable access system
ApplicantSMITHS MEDICAL MD, INC.
PMA NumberP900052
Supplement NumberS014
Date Received12/08/2006
Decision Date08/28/2007
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 change to the in-process manufacturing package inspection procedure of the port-a-cath epidural and port-a-cath ii low profile epidural systems. The modifications to the in-process pouch seal inspection includes: 1) five test intervals will be performed over a single day versus three test intervals per each manufacturing job. 2) the current five pouches tested using the pull test will be reduced to two pouches per test period and the current two pouches inspected using hand peel and visual verification will be increased to five pouches per test period. 3) the results of the gage pull test and visual inspection will be recorded in the individual job folder per established test interval. 4) the pouch sealing process parameter settings will continue to be recorded for each job and each inspection interval.
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