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Device | BRIO CARDIAC PACEMAKERS DUAL CHAMBER/DUAL CHAMBER RATE RESPONSIVE |
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 | S005 |
Date Received | 02/26/1999 |
Decision Date | 08/25/1999 |
Product Code |
DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for access to programmable rest-rate and non-invasive physiological stimulation (NIPS) parameters. The device is indicated for dual-chamber cardiac pacing with the ability to perform limited non-invasive electrophysiological studies. |