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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.
 
DeviceINFUSAID IMPLANTABLE INFUSION PUMP
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
CODMAN & SHURTLEFF, INC.
325 paramount dr.
raynham, MA 02767-0350
PMA NumberP800036
Supplement NumberS035
Date Received10/21/1997
Decision Date12/19/1997
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for packaging and sterilizing the Arrow 22 gauge non-coring needle inside the Strato/Infusaid Refill Kit (#103381) in addition to the individually packaged sterile needle configuration.
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