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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.
 
DeviceMEDTRONIC ONE PIECE VASCULAR CATHETERS
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS045
Date Received03/29/2000
Decision Date04/14/2000
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for changes in the Anchor Rings - The anchor rings at the tip of the Model 8700A catheter are to be changed from a tapered design to a smaller, rounded bead design at the distal end of the catheter; changes to the Catheter Tubing Composition - the composition of the tubing for the Model 8700A, Model 8700V, and Model 8702 catheters is to be changed to Biomedical Grade ETR Q7-4765; changes to the Technical Manual - the Model 8700A, Model 8700V, and Model 8702 catheters are covered in the same technical manual.
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