PMA P110042S160

Device: EMBLEM S-ICD PG models A209 and A219.
Applicant: Boston Scientific Corporation
Product code: LWS
Decision date: 2021-10-19
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: Add second suppliers for the PCB and RF Crystal components; modification to the manufacturing material of the RF Crystal component from the new supplier, and correction to design specification for the EMBLEM S-ICD PG models A209 and A219.

Current openFDA PMA Record#

Device: EMBLEM S-ICD PG models A209 and A219.
Applicant: Boston Scientific Corporation
PMA number: P110042
Supplement: S160
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2021-10-19
Decision code: OK30
Date received: 2021-09-20
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Add second suppliers for the PCB and RF Crystal components; modification to the manufacturing material of the RF Crystal component from the new supplier, and correction to design specification for the EMBLEM S-ICD PG models A209 and A219.