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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.
 
DeviceCOROX OTW-L BP LEFT VENTRICULAR PACING LEAD
Generic NamePulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP070008
Supplement NumberS015
Date Received02/24/2010
Decision Date12/23/2010
Product Code NKE 
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 THE COROX OTW-L BP MODEL LEFT VENTRICULAR LEAD WHICH INCORPORATES A DIFFERENT DISTAL TIP GEOMETRY COMPARED TO THE MARKET-APPROVED COROX OTW BP LEADS.
Approval OrderApproval Order
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