FDA.reportPublic FDA data

PMA P030054S378

Device
Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex µ, Quartet, and Quartet CRT Leads
Applicant
ABBOTT MEDICAL
PMA number
P030054
Supplement
S378
Product code
NIK
Decision date
2020-05-21
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
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
Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex µ, Quartet, and Quartet CRT Leads
Applicant
ABBOTT MEDICAL
PMA number
P030054
Supplement
S378
Product code
NIK
Generic name
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
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.