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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.
 
DevicePROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantAlgorithm Sciences, Inc.
121 Shelley Drive
2H
Hackettstown, NJ 07840
PMA NumberP080012
Supplement NumberS003
Date Received03/06/2012
Decision Date05/04/2012
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol - OSB
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE POST-APPROVAL STUDY PROTOCOL.
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