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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 ADAPTA, VERSA AND SENSIA IMPLANTABLE PULSE GENERATORS (IPG) PRODUCT FAMILY
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pulse generator programming software
Applicant MEDTRONIC INC.
PMA NumberP980035
Supplement NumberS101
Date Received06/20/2008
Decision Date07/18/2008
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in vendor for selected integrated circuits (ics) used in the hybrids for manufacturing the adapta, versa, and sensia implantable pulse generators (ipgs).
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