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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, IDENTITY, IDENTITY ADX, INTEGRITY ADX, VERITY ADX, VICTORY, ZEPHER, MICRONY PACEMAKERS
Generic NamePulse generator, permanent, implantable
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP880086
Supplement NumberS202
Date Received04/19/2011
Decision Date12/04/2012
Product Code NVZ 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR A MATERIAL CHANGE FROM MEDICAL GRADE POLYSULFONE TO BIOGRADE POLYSULFONE.
Approval OrderApproval Order
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