|
Device | VARIOUS FAMILIES OF PACEMAKERS |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P950029 |
Supplement Number | S036 |
Date Received | 06/10/2008 |
Decision Date | 09/10/2008 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE PROGRAMMER APPLICATION SOFTWARE PACKAGE VERSION SMARTVIEW 2.02 UG4 FOR ORCHESTRA AND ORCHESTRA PLUS PROGRAMMERS. |