PMA P960040S469

Device: ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD AUTOGEN VR, ICD AUTOGEN
Applicant: Boston Scientific
PMA number: P960040
Supplement: S469
Product code: LWS
Decision date: 2021-09-20
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: Update the general visual inspection criteria for cathode damage observed during high voltage capacitor manufacturing used in NG3 ICDs and CRT-Ds.

Current openFDA PMA Record#

Device: ICD ORIGEN VR, ICD ORIGEN DR, ICD INOGEN VR, ICD INOGEN DR, ICD DYNAGEN VR, ICD DYNAGEN DR, ICD AUTOGEN VR, ICD AUTOGEN
Applicant: Boston Scientific
PMA number: P960040
Supplement: S469
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2021-09-20
Decision code: OK30
Date received: 2021-09-13
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Update the general visual inspection criteria for cathode damage observed during high voltage capacitor manufacturing used in NG3 ICDs and CRT-Ds.