|
Device | ACTUITY X4 QUADRIPOLAR CORONARY VENOUS PACE/SENSE LEADS |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S443 |
Date Received | 01/13/2017 |
Decision Date | 07/24/2017 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement approval for creating a duplicate manufacturing line at the Boston Scientific Corporation, No.12, Road 698, Dorado, Puerto Rico facility for the ACTUITY X4 Quadripolar Coronary Venous Pace/Sense Leads. |