|
Device | FINLINE LEAD FAMILY |
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 | S061 |
Date Received | 05/16/2013 |
Decision Date | 08/07/2013 |
Product Code |
NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR LEAD STABILIZER KIT 6503 AND LEAD CAP KIT 6504, WHICH ARE ACCESSORY KITS INTENDED TO BE USED WITH THE BOSTON SCIENTIFIC CORPORATION (BSC) LEAD PRODUCTS APPROVED IN THE DEVICES. |