|
Device | RELIATY / MODEL 3145 FAMILY OF PACING SYSTEM ANALYZERS |
Generic Name | Pulse Generator, External Pacemaker, Dual Chamber |
Regulation Number | 870.3600 |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S088 |
Date Received | 10/06/2010 |
Decision Date | 04/20/2011 |
Product Code |
OVJ |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Review Memo | Review Memo |
Approval Order Statement APPROVAL FOR: 1) NEW DISPLAY SCREEN; 2) ALTERNATE BATTERY; 3) MODIFIED BATTERY CARTRIDGE; 4) MODIFIED BATTERY CONTACTS; 5) NEW FIRMWARE; 6) UPDATED SOFTWARE; 7) MODIFIED CONTROL KNOB; 8) MODIFIED CIRCUIT BOARDS; AND 9) TECHNICAL MANUAL AND DEVICE LABELING CHANGES. |
Approval Order | Approval Order |