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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.
 
DeviceOPTISENSE 1999 LEAD
Generic NameDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP960013
Supplement NumberS058
Date Received03/23/2010
Decision Date05/19/2010
Product Code NVN 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR NEW STYLETS TO BE INCLUDED IN THE OPTISENSE MODEL 1999 LEAD PACKAGE.
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