PMA P110042S176

Device: EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
Applicant: Boston Scientific Corporation
PMA number: P110042
Supplement: S176
Product code: LWS
Decision date: 2022-12-07
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: Modification of electrical test software to ensure that the correct date and time stamp are loaded at Final Pack of the EMBLEM S-ICD pulse generators.

Current openFDA PMA Record#

Device: EMBLEM™ Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)
Applicant: Boston Scientific Corporation
PMA number: P110042
Supplement: S176
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2022-12-07
Decision code: OK30
Date received: 2022-11-10
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Modification of electrical test software to ensure that the correct date and time stamp are loaded at Final Pack of the EMBLEM S-ICD pulse generators.