|
Device | RX5000 (TM) GRAPHICS PROGRAMMER |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | BOSTON SCIENTIFIC 4100 Hamline Avenue North St. Paul, MN 55112 |
PMA Number | P830026 |
Supplement Number | S070 |
Date Received | 03/14/1997 |
Decision Date | 04/17/1997 |
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 FOR THE RX5000 MODEL 522-12 VERSION 2.01.03 OPERATING SYSTEM. |