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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.
 
DeviceAFFINITY PULSE GENERATORS
Generic Nameimplantable pacemaker Pulse-generator
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP880086
Supplement NumberS075
Date Received08/01/2000
Decision Date08/15/2000
Product Codes DTB DXY KRG 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR REMOVAL OF THE PARYLENE COATING FROM THE AFFINITY MODELS DR 5330, SR 5130, DC 5230, ENTITY DR 5326, AND ENTITY DC 5226 PULSE GENERATORS.
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