|
Device | FINELINE II STEROX EZ 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 | S041 |
Date Received | 08/25/2008 |
Decision Date | 10/09/2008 |
Product Code |
NVN |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE MANNITOL BULLET FORMING FIXTURE AND LEAD TIP PROTECTOR FOR THE DEVICE. |