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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 DR RF,ACCENT SR RF PACEMAKER DEVICES
Generic NamePulse generator, permanent, implantable
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP880086
Supplement NumberS234
Date Received08/06/2013
Decision Date09/05/2013
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE ENCAPSULATION CURE PROCESS FOR THE LEFT VENTRICULAR RADIOFREQUENCY (LV RF) MODULES IN THE DEVICES.
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