PMA P030054S400

Device: Quickflex µ, Quartet
Applicant: ABBOTT MEDICAL
PMA number: P030054
Supplement: S400
Product code: NIK
Decision date: 2022-08-01
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: Implementation of the automated system Vaisala EMS system for environmental and process equipment monitoring at the Rogers, Minnesota manufacturing site.

Current openFDA PMA Record#

Device: Quickflex µ, Quartet
Applicant: ABBOTT MEDICAL
PMA number: P030054
Supplement: S400
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2022-08-01
Decision code: OK30
Date received: 2022-07-14
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of the automated system Vaisala EMS system for environmental and process equipment monitoring at the Rogers, Minnesota manufacturing site.