PMA P110042S174

Device: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
Applicant: Boston Scientific Corporation
Product code: LWS
Decision date: 2022-12-12
Generic name: Implantable cardioverter defibrillator (non-CRT)
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: Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
Applicant: Boston Scientific Corporation
PMA number: P110042
Supplement: S174
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
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.