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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 NameMEDTRONIC SYNCHROMED INFUSION SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Nameimplanted infusion pump
ApplicantMEDTRONIC VASCULAR
PMA NumberP860004
Supplement NumberS036
Date Received02/27/1997
Decision Date07/17/1997
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of an alternative bead blasted shield surface finish long with an associated change to the laser engraving for the medtronic synchromed pump's titanium shields. The bead blasted shield finish, and associated continuous laser power engraving process, may serve as an alternative to the current straight line shield finish in that either finish may be used on the device.
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