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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 PROGRAMMABLE DRUG INFUSION SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Namesynchromed & isomed implantable infusion pumps
ApplicantMEDTRONIC NEUROLOGICAL
PMA NumberP860004
Supplement NumberS082
Date Received03/17/2006
Decision Date03/30/2006
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the following modification: 1) shortening length of bulkhead inlet feature by 0. 8 mm (0. 03149 inches) from 3. 0 mm to 2. 2 mm; and 2) increasing radius of outer wall of bulkhead electronic chamber pocket by 0. 3 mm (0. 0118 inches) from 34. 5 mm (1. 358264 inches to 34. 8 mm (1. 370075 inches).
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