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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.
 
DeviceSURESTREAM INTRASPINAL CATHETER KIT (60-2918) & SURESTREAM REPLACEMENT CONNECTOR AND STRAIN RELIEF SLEEVE (60-2950)
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
CODMAN
325 paramount dr.
raynham, MA 02767
PMA NumberP890055
Supplement NumberS025
Date Received12/11/2007
Decision Date10/10/2008
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
APPROVAL FOR: 1) A NEW MANUFACTURING FACILITY, CODMAN NEUROSCIENCES, SARL, LELOCLE, SWITZERLAND AND 2) THE ADDITIONAL DEVICE ACCESSORIES FOR THE CODMAN 3000 CONSTANT FLOW IMPLANTABLE INFUSION PUMP ¿ SURESTREAM INTRASPINAL CATHETER KIT (60-2918) & SURESTREAM REPLACEMENT CONNECTOR AND STRAIN RELIEF SLEEVE (60-2950).
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