|
Device | EASY TRAK 2 FAMILY |
Generic Name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S375 |
Date Received | 10/07/2014 |
Decision Date | 10/22/2014 |
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 | Yes |
Approval Order Statement UPDATE THE PROXIMAL ELECTRODE LASER WELDING PARAMETERS FOR WELDING THE PROXIMAL ELECTRODE TO THE LEAD COIL. |