|
Device | EASYTRAK IS-1 AND EASYTRAK LV-1 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 | S139 |
Date Received | 09/11/2006 |
Decision Date | 03/06/2007 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Other |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR ADDING POST APPROVAL STUDY (PAS) DATA TO THE EASYTRAK IS-1 AND EASYTRAK LV-1 PHYSICIAN MANUALS. |