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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 NumberS037
Date Received02/28/1997
Decision Date06/28/1999
Product Code
LKK[ Registered Establishments with LKK ]
Docket Number N
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason labeling change - performance characteristics
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a labeling change to include the use of the synchromed infusion system in a magnetic resonance imaging (mri) environment.
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