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Device | ESPRIT MODELS SR AND DR PACEMAKER SYSTEMS WITH THE PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.16 UG1 |
Generic Name | Pulse generator, permanent, implantable |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P950029 |
Supplement Number | S041 |
Date Received | 03/02/2009 |
Decision Date | 06/11/2009 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE ESPRIT MODELS SR AND DR PACEMAKER SYSTEMS WITH THE PROGRAMMER APPLICATION SOFTWARE VERSION SMARTVIEW 2.16 UG1. |