FDA.reportPublic FDA data

PMA P140033S058

Device
Assurity MRI and Endurity MRI
Applicant
ABBOTT MEDICAL
PMA number
P140033
Supplement
S058
Product code
LWP
Decision date
2020-05-21
Generic name
Implantable pulse generator, pacemaker (non-CRT)
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
Assurity MRI and Endurity MRI
Applicant
ABBOTT MEDICAL
PMA number
P140033
Supplement
S058
Product code
LWP
Generic name
Implantable pulse generator, pacemaker (non-CRT)
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.