|
Device | OVATIO VR/DR AND PARADYM VR/DR ICDS |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S057 |
Date Received | 05/17/2010 |
Decision Date | 06/28/2010 |
Product Code |
MRM |
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 PROGRAMMER SOFTWARE VERSION SMARTVIEW 2.20UG1 FOR USE WITH THE OVATION AND PARADYM ICDS AND CRT-DS AND THE REPLY AND ESPRIT PACEMAKERS. |