PMA P010012S526

Device: CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL
Applicant: Boston Scientific Corp
Product code: NIK
Decision date: 2020-11-12
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: Approval to suspend enrollment in the MANAGE-HF Phase II Post-Approval Study for six (6) months due to COVID-19.

Current openFDA PMA Record#

Device: CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S526
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2020-11-12
Decision code: APPR
Date received: 2020-10-16
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: Approval to suspend enrollment in the MANAGE-HF Phase II Post-Approval Study for six (6) months due to COVID-19.