|
Device | FINELINE 2 PACING LEADS |
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 | S070 |
Date Received | 06/22/2015 |
Decision Date | 07/16/2015 |
Product Code |
NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement ADD AN AUTOMATED VISION SYSTEM LABEL INSPECTION TO THE FINAL PACKAGING LINE, REMOVE REDUNDANT IN-PROCESS INSPECTION AND MOVE UPSTREAM VALIDATED INSPECTIONS TO A DOWNSTREAM STEP. |