|
Device | PROGRAMMING SOFTWARE UPGRADE (CSO 4.10 UG) |
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 | S009 |
Date Received | 10/12/1999 |
Decision Date | 11/19/1999 |
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 CSO 4.10 UG Programmer Software, for use with the ELA programmers. |