PMA P010012S560

Device: Cardiac Resynchronization Therapy Defibrillator (CRT-D)
Applicant: Boston Scientific Corp
Product code: NIK
Decision date: 2022-12-12
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Approval order statement: Approval for modifications to the product labeling for the Accolade family of pacemakers and cardiac resynchronization therapy pacemakers to provide additional clarity.

Current openFDA PMA Record#

Device: Cardiac Resynchronization Therapy Defibrillator (CRT-D)
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S560
Product code: NIK
Generic name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
Decision date: 2022-12-12
Decision code: APPR
Date received: 2022-09-30
Supplement type: Real-Time Process
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for modifications to the product labeling for the Accolade family of pacemakers and cardiac resynchronization therapy pacemakers to provide additional clarity.