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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 NameSYNCHROMED II AND SYNCHROMED EL DRUG PUMPS
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
PMA NumberP860004
Supplement NumberS193
Date Received07/15/2013
Decision Date08/05/2013
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Supplier be cleared to manufacture a printed circuit board assembly at an alternate facility.
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