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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 NameMEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator programming software
Applicant MEDTRONIC INC.
PMA NumberP980035
Supplement NumberS098
Date Received06/02/2008
Decision Date10/01/2008
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at plexus services corp. , plexus-penang, penang, malaysia, for the testing, labeling and packaging of the device.
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