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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 MODEL 1999 LEAD
Generic NameDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
ApplicantAbbott Medical
15900 Valley View Court
Symar, CA 91335
PMA NumberP960013
Supplement NumberS057
Date Received03/12/2010
Decision Date11/26/2010
Product Code NVN 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR A DESIGN CHANGE TO THE HEADER COUPLING (FROM A MACHINED COMPONENT TO A MOLDED COMPONENT) OF THE OPTISENSE MODEL 1999 PACING AND SENSING LEAD.
Approval OrderApproval Order
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