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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.
 
DeviceSYNCHROMED II PROGRAMMABLE DRUG INFUSION SYSTEM
Classification Namepump, infusion, implanted, programmable
Generic Namepump, infusion, implanted, programmable
Applicant
MEDTRONIC Inc.
7000 central avenue ne
minneapolis, MN 55432-3576
PMA NumberP860004
Supplement NumberS082
Date Received03/15/2006
Decision Date03/30/2006
Product Code
LKK[ Registered Establishments with LKK ]
Advisory Committee General Hospital
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
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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