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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.
 
DeviceSYNCHROMED II IMPLANTABLE INFUSION SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantMEDTRONIC Inc.
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432-3576
PMA NumberP860004
Supplement NumberS070
Date Received03/31/2005
Decision Date09/26/2005
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE MODEL 8832 PERSONAL THERAPY MANAGER (PTM), AN ACCESSORY TO THE SYNCHROMED II IMPLANTABLE INFUSION SYSTEM, INDICATED FOR THE PATIENT TO ACTIVATE DELIVERY OF PHYSICIAN PROGRAMMED SUPPLEMENTAL DOSES OF PRESERVATIVE-FREE MORPHINE SULFATE STERILE SOLUTION FROM THE SYNCHROMED II PUMP FOR THE TREATMENT OF CHRONIC INTRACTABLE PAIN.
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