|
Device | EASYTRAK 3 FAMILY OF LEADS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S167 |
Date Received | 12/17/2007 |
Decision Date | 02/11/2008 |
Product Code |
LWP |
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 REPLACEMENT OF THE CURRENT REHAU SI-1511 MEDICAL ADHESIVE IN THE LEADS WITH MED-1515 MEDICAL ADHESIVE. |