|
Device | CYLOS FAMILY OF PULSE GENERATORS |
Generic Name | permanent pacemaker Electrode |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S041 |
Date Received | 09/26/2005 |
Decision Date | 12/21/2005 |
Product Codes |
DTB DXY |
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 CYLOS DR/DR-T AND CYLOS VR PULSE GENERATORS AND THE A-K00.6.U PROGRAMMER SOFTWARE (FOR USE WITH THE EPR 1000PLUS AND TMS 1000 PLUS PROGRAMMERS); THE 504.U PROGRAMMER SOFTWARE (FOR USE WITH THE ICS 3000 PROGRAMMER; AND THE HOME MONITORING SERVICE CENTER II VERSION 1.8.0. |