|
Device | SYMPHONY/ELA RHAPSODY ROM MASK T3 (VERSION GXD T3) |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P950029 |
Supplement Number | S019 |
Date Received | 12/04/2003 |
Decision Date | 02/13/2004 |
Product Code |
DXY |
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 THE FIRMWARE MODIFICATIONS (VERSION GXD T3) OF THE SYMPHONY AND ELA RHAPSODY PACEMAKERS. |