PMA P010012S540

Device: Resonate family of CRT-D's
Applicant: Boston Scientific Corp
Product code: NIK
Decision date: 2021-10-07
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: Approval for labeling updates to reflect findings of the Strategic Management to Improve CRT (SMART) Multi-Site Pacing (MSP) clinical study.

Current openFDA PMA Record#

Device: Resonate family of CRT-D's
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S540
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2021-10-07
Decision code: APPR
Date received: 2021-07-07
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Labeling Change - PAS
Approval order statement: Approval for labeling updates to reflect findings of the Strategic Management to Improve CRT (SMART) Multi-Site Pacing (MSP) clinical study.