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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 PUMP
ApplicantMEDTRONIC NEUROMODULATION
PMA NumberP860004
Supplement NumberS097
Date Received03/10/2008
Decision Date08/18/2008
Advisory Committee General Hospital
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changing the workstations used for welding battery header subassemblies.
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