|
Device | ELAVIEW 1.26 UG APPLICATION SOFTWARE FOR THE ORCHESTRA PROGRAMMER; RAM PATCHES ALTO P4 AND ALTO2 P3; AND HSO 2.70 SOFTWA |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P980049 |
Supplement Number | S017 |
Date Received | 09/15/2004 |
Decision Date | 12/08/2004 |
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 THE ELAVIEW 1.26 UG APPLICATION SOFTWARE FOR THE ORCHESTRA PROGRAMMER; RAM PATCHES ALTO P4 AND ALTO2 P3; AND HSO 2.70 SOFTWARE FOR THE CPR3 PROGRAMMING HEAD. |