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Device | TACHOS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS AND PROGRAMMER SOFTWARE VERSION A-K00.1.U/5 |
Generic Name | DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P000009 |
Supplement Number | S011 |
Date Received | 03/03/2004 |
Decision Date | 04/22/2004 |
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 THE AUTOMATIC BATTERY MANAGEMENT FEATURE FOR THE TACHOS FAMILY IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEMS AND PROGRAMMER SOFTWARE VERSION A-K00.1.U/5. |