|
Device | NON-RATE RESPONSIVE PACEMAKERS |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P900022 |
Supplement Number | S007 |
Date Received | 07/11/2006 |
Decision Date | 07/26/2006 |
Product Code |
LWP |
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 ELAVIEW 1.34 UGI PROGRAMMING SOFTWARE. |