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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.
 
DeviceSYNCHROMED PUMP AND INFUSION SYSTEM
Applicant
MEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS103
Date Received12/15/2008
Decision Date01/14/2009
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 
REDUCTION IN THE SAMPLING FREQUENCY OF ROUTINE ENVIRONMENTAL MONITORING AT THE FACILITY LOCATED IN JUNCOS, PUERTO RICO.
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