|
Device | ORCHESTRA PLUS PROGRAMMER & ELAVIEW 2.02 UG1 PROGRAMMING SOFTWARE |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P900022 |
Supplement Number | S008 |
Date Received | 01/24/2007 |
Decision Date | 06/29/2007 |
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 FOR THE ORCHESTRA PLUS PROGRAMMER AND ELAVIEW 2.02 PROGRAMMING SOFTWARE. |