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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
Generic Namepump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS040
Date Received01/15/1998
Decision Date04/13/1998
Product Code LKK 
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Expedited Review Granted? No
Combination ProductNo
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.