|
Device | SELECTED MODELS OF DUAL CHAMBER ICD DEVICES |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P000009 |
Supplement Number | S021 |
Date Received | 10/12/2006 |
Decision Date | 01/30/2007 |
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 MINOR CHANGES TO THE RF CIRCUITRY IN THE LEXOS AND LUMOS FAMILIES OF IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND APPROVAL FOR UPDATED SOFTWARE VERSIONS TO CORRECT BRADYCARDIA AND TACHYCARDIA SOFTWARE ANOMALIES. |