|
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 | S134 |
Date Received | 06/26/2006 |
Decision Date | 07/26/2006 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement CHANGES TO THE SOFTWARE LOAD PROCESS FOR THE MODEL 3120 ZOOM LATITUDE PROGRAMMER USED WITH THE DEVICES. |