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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.
 
DeviceCODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP.
Generic NamePump, infusion, implanted, programmable
ApplicantIntera Oncology
180 Wells Ave., Suite 300a
Newton, MA 02459
PMA NumberP890055
Supplement NumberS062
Date Received04/27/2016
Decision Date05/27/2016
Product Code LKK 
Advisory Committee General Hospital
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Change for a new packaging equipment to seal the pouches for the Codman 3000 Constant-Flow Implantable Infusion Pump O.R. Prep Kit Tubing Assembly. External supplier, Command Medical Products (Command), has requested implementation of new packaging sealing equipment, a Sencorp bar sealer (12-PL/2) with a removable work surface. The supplier has requested the change as a process improvement.
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