|
Device | APSU PROGRAMMER, APSU SOFTWARE, BASE STATION |
Generic Name | implantable pacemaker Pulse-generator |
Regulation Number | 870.3610 |
Applicant | Abbott Medical 15900 Valley View Court Sylmar, CA 91335 |
PMA Number | P880086 |
Supplement Number | S046 |
Date Received | 03/06/1998 |
Decision Date | 09/03/1998 |
Product Code |
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 modifications to the approved labeling including: the addition of a "Cellular Tested" logo and associated language in the Patient and Physican manuals specifying those cellular telephone protocols for which testing has been peroformed and shown no interaction. |