|
Device | CONTAK CD/EASYTRACK CRT-D SYSTEM |
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 | S265 |
Date Received | 03/18/2011 |
Decision Date | 05/17/2011 |
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 AN UPDATE TO THE MODEL 2909 SYSTEM SOFTWARE V8.01 AND THE ADDITION OF MODEL 2905 PDF REPORT GENERATOR V1.01. |