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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePORT-A-CATH II LOW PROFILE EPIDURAL IMPLANTABLE ACCESS SYSTEM
Generic NameCATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
ApplicantSMITHS MEDICAL ASD, INC.
1265 Grey Fox Road
St. Paul, MN 55112
PMA NumberP900052
Supplement NumberS015
Date Received05/25/2007
Decision Date11/06/2007
Withdrawal Date 12/26/2018
Product Code LNY 
Advisory Committee General Hospital
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL TO USE THE HERRMANN ULTRASONIC WELDER.
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