FDA.reportPublic FDA data

PMA P880086S313

Device
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S313
Product code
DXY
Decision date
2020-05-21
Generic name
implantable pacemaker Pulse-generator
Approval order statement
Implementation of an automated system, Vaisala EMS, for process monitoring to replace existing chart recorders and electronic monitoring systems at the Abbott/St. Jude Medical Scottsdale, Arizona component manufacturing site.

Current openFDA PMA Record#

Device
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust
Applicant
ABBOTT MEDICAL
PMA number
P880086
Supplement
S313
Product code
DXY
Generic name
implantable pacemaker Pulse-generator
Decision date
2020-05-21
Decision code
OK30
Date received
2020-04-24
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of an automated system, Vaisala EMS, for process monitoring to replace existing chart recorders and electronic monitoring systems at the Abbott/St. Jude Medical Scottsdale, Arizona component manufacturing site.