PMA P880086S046

Device: APSU PROGRAMMER, APSU SOFTWARE, BASE STATION
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S046
Product code: DXY
Decision date: 1998-09-03
Classification: Implantable Pacemaker Pulse-generator
Generic name: implantable pacemaker Pulse-generator
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.

Current openFDA PMA Record#

Device: APSU PROGRAMMER, APSU SOFTWARE, BASE STATION
Applicant: ABBOTT MEDICAL
PMA number: P880086
Supplement: S046
Product code: DXY
Generic name: implantable pacemaker Pulse-generator
Decision date: 1998-09-03
Decision code: APPR
Date received: 1998-03-06
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
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.