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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 PROGRAMMABLE DRUG INFUSION SYSTEM
Generic NamePump, infusion, implanted, programmable
ApplicantMedtronic, Inc.
7000 Central Ave., NE
Minneapolis, MN 55432
PMA NumberP860004
Supplement NumberS082
Date Received03/15/2006
Decision Date03/30/2006
Product Code LKK 
Advisory Committee General Hospital
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
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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