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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 NameIMPLANTABLE DRUG DELIVERY SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Nameimplanted infusion pump
ApplicantCODMAN & SHURTLEFF, INC.
PMA NumberP800036
Supplement NumberS037
Date Received11/24/2010
Decision Date12/22/2010
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type30-day notice
Supplement Reason process change: sterilization
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Implementation of a parametric release process for ethylene oxide sterilized products.
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