FDA.reportPublic FDA data

PMA P030035S181

Device
Allure, Allure Quadra, and Quadra Allure MP
Applicant
ABBOTT MEDICAL
PMA number
P030035
Supplement
S181
Product code
NKE
Decision date
2020-05-21
Generic name
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
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
Allure, Allure Quadra, and Quadra Allure MP
Applicant
ABBOTT MEDICAL
PMA number
P030035
Supplement
S181
Product code
NKE
Generic name
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)
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.