|
Device | ACTROS SLR PULSE GENERATOR |
Generic Name | permanent pacemaker Electrode |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P950037 |
Supplement Number | S013 |
Date Received | 05/08/2000 |
Decision Date | 10/13/2000 |
Product Codes |
DTB DXY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR REMOVAL OF THE WARNING LABEL WHICH RECOMMENDED PROGRAMMING DYNAMIC HYSTERESIS ON WHEN THE DEVICE IS PROGRAMMED TO THE VDDR MODE. |