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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.
 
DeviceFINELINE II STEROX AND STEROX EZ ENDOCARDIAL PACING LEAD
Generic NameDrug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes
ApplicantBoston Scientific
4100 Hamline Ave. N
St Paul, MN 55112
PMA NumberP960004
Supplement NumberS059
Date Received03/27/2013
Decision Date10/08/2015
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
Approval Order Statement  
APPROVAL FOR THE FOLLOWING:1) A STERILIZATION PROCESS CHANGE FROM OXYFUME TO 100% ETHYLENE OXIDE;2) DRUG SPECIFICATION CHANGES; 3) LABELING CHANGES; 4) TO FINISH REMAINING 3 MONTHS OF LOT RELEASE STUDY FOR PASSIVE FIXATION LEADS AS NON-CLINICAL POST APPROVAL STUDY;4) MANUFACTURING CHANGES TO REDUCE ELUTION VARIATION;5) TO UPDATE ACTIVE FIXATION BATCH RELEASE STUDY PROTOCOL TO IMPLEMENT NEW MANUFACTURING CHANGES; AND6) TO COMPLETE 12 MONTH LOT RELEASE STUDY AS NON-CLINICAL POST APPROVAL STUDY.
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