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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSYNCHROMED II IMPLANTABLE INFUSION SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Nameimplantable infusion pumps
ApplicantMEDTRONIC NEUROLOGICAL
PMA NumberP860004
Supplement NumberS070
Date Received03/31/2005
Decision Date09/26/2005
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
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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