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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
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
65 William Street
Suite 2000
Wellesley, MA 02481
PMA NumberP800036
Supplement NumberS035
Date Received10/21/1997
Decision Date12/19/1997
Withdrawal Date 03/12/2021
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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