PMA P880086S067

Device
3500/3510 PROGRAMMER
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S067
Product code
DXY
Decision date
2000-01-28
Classification
Implantable Pacemaker Pulse-generator
Generic name
implantable pacemaker Pulse-generator
Approval order statement
Approval is for the Model 3304 Programmer Software for use with the Model 3500 and 3510 Programmers. The device is indicated for programming and interrogation of implanted St. Jude pacemakers.

Current openFDA PMA Record#

Device
3500/3510 PROGRAMMER
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S067
Product code
DXY
Generic name
implantable pacemaker Pulse-generator
Decision date
2000-01-28
Decision code
APPR
Date received
1999-07-22
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval is for the Model 3304 Programmer Software for use with the Model 3500 and 3510 Programmers. The device is indicated for programming and interrogation of implanted St. Jude pacemakers.