|
Device | CONTAK CD/EASYTRAK 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 | S254 |
Date Received | 08/23/2010 |
Decision Date | 09/14/2010 |
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 CHANGES TO THE MODEL 3120 PROGRAMMER SYSTEM SOFTWARE MODEL 2909 FROM VERSION 6.01 TO VERSION 7.01. |