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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 Nameimplantable infusion pumps
ApplicantMEDTRONIC VASCULAR
PMA NumberP860004
Supplement NumberS040
Date Received01/15/1998
Decision Date04/13/1998
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to modify the prescription caution statement on the synchromed prouduct labeling from "caution: federal law restricts this device to sale, distribution, and use by or on the order of a physician," to that specified in 21 cfr 801. 109(b)(1), "caution: federal law restricts this device to sale by or on the order of a physician". Fda also acknowledges and approves the substitution of "(usa)" for "federal law" for devices distributed outside of the united states.
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