Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | BRIO, TALENT, AND OPUS PACEMAKERS AND PROGRAMMER SOFTWARE |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | MicroPort CRM USA Inc. 5640 Airline Road Arlington, TN 38002 |
PMA Number | P950029 |
Supplement Number | S013 |
Date Received | 01/11/2001 |
Decision Date | 02/02/2001 |
Product Code |
DXY |
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 A NEW DIGITAL PACING CHIP, THE LOGAUTO H5, BRIO AND TALENT FIRMWARE MASK L4, AND CSO VERSION 4.16UG PROGRAMMER SOFTWARE. |
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