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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.
 
DeviceDEXTRUS, SELOX ST/JT, SETROX S, AND TILDA T/JT/R STEROID-ELUTING PACING LEADS; SOLOX SLX -BP PACING LEAD
Generic NamePulse generator, permanent, implantable
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP950037
Supplement NumberS138
Date Received07/28/2014
Decision Date09/16/2014
Product Code NVZ 
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 FOLLOWING CHANGES:1) A MINOR MODIFICATION (ADDITION OF INNER COATING) OF TO THE LINOXSMART/ VOLTA/PROTEGOICD LEADS;2) MODIFICATIONS TO THE CURRENT SUTURE SLEEVE TO CREATE A WHITE SUTURE SLEEVE; 3) PA 11 ADAPTER; AND4) LEAD TECHNICAL MANUAL/LABELING UPDATES.
Approval OrderApproval Order
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