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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.
Classification Namepump, infusion, implanted, programmable
PMA NumberP860004
Supplement NumberS191
Date Received04/25/2013
Decision Date05/23/2013
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type Special Supplement
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval of labeling changes for device refill kit model 8551 to accommodate the possibility for the use of multiple syringes during kit refill procedures.