|
Device | PULSAR/PULSAR MAX/ DISCOVERY/MERIDIAN |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P940031 |
Supplement Number | S061 |
Date Received | 08/23/2007 |
Decision Date | 12/20/2007 |
Product Code |
LWP |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL TO UPDATE THE SYSTEM SOFTWARE MODEL 2909 FROM V4.4 TO V6.0 FOR THE RUN TIME ENVIRONMENT OF THE MODEL 3120 PRM. |