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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.
 
DeviceACCENT SR RF, ACCENT DR RF PACEMAKERS
Generic NamePulse generator, permanent, implantable
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP880086
Supplement NumberS244
Date Received06/12/2014
Decision Date07/09/2014
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
MODIFY THE DEVICE POST STERILIZATION TEST (DPST) AT ATE FOR THE RF TELEMETRY OF THE DEVICES.
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