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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 NameDRUG DELIVERY CATHETERS, DRUG DELIVERY INFUSION PUMP SYNCHROMED FAMILY, DRUG DELIVERY KITS FOR REVISIONS
Classification Namepump, infusion, implanted, programmable
ApplicantMEDTRONIC NEUROMODULATION
PMA NumberP860004
Supplement NumberS197
Date Received09/23/2013
Decision Date10/22/2013
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Increase the use before date storage shelf life of the tyvek lid packaging component used in the sterile packaging configuration of multiple implantable neuromodulation products.
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