|
Device | FINELINE II STEROX AND STEROX EZ ENDOCARDIAL PACING LEAD |
Generic Name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P960004 |
Supplement Number | S059 |
Date Received | 03/27/2013 |
Decision Date | 10/08/2015 |
Product Code |
NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
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. |