PMA P030054S372

Device: Quadripolar Pacing
Applicant: ABBOTT MEDICAL
PMA number: P030054
Supplement: S372
Product code: NIK
Decision date: 2019-12-20
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: Approval for updates to the user’s manual to include a new section that reflects long-term safety and effectiveness data from the Quadripolar Pacing Post Approval Study.

Current openFDA PMA Record#

Device: Quadripolar Pacing
Applicant: ABBOTT MEDICAL
PMA number: P030054
Supplement: S372
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2019-12-20
Decision code: APPR
Date received: 2019-10-09
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for updates to the user’s manual to include a new section that reflects long-term safety and effectiveness data from the Quadripolar Pacing Post Approval Study.