|
Device | EASYTRAK 3 IS-1 LEAD MODELS: 4548/4549/4550 |
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 | S032 |
Date Received | 09/23/2004 |
Decision Date | 11/24/2004 |
Product Code |
LWP |
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 CHANGE OF LEAD CONNECTOR FROM LV-1 TO IS-1. |