PMA P010012S409

Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR, NG3 CRT-D DYNAGEN CRT-D & X4 CRT-D, INOGEN CRT-D & X4 CRT-D. ORIGEN CRT
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S409
Product code: LWS
Decision date: 2016-03-03
Classification: Implantable Cardioverter Defibrillator (non-crt)
Generic name: Implantable cardioverter defibrillator (non-CRT)
Approval order statement: Approval for updates to the Physician’s Technical Manuals (PTMs) for ICDs and CRT-Ds

Current openFDA PMA Record#

Device: CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR, NG3 CRT-D DYNAGEN CRT-D & X4 CRT-D, INOGEN CRT-D & X4 CRT-D. ORIGEN CRT
Applicant: Boston Scientific Corp
PMA number: P010012
Supplement: S409
Product code: LWS
Generic name: Implantable cardioverter defibrillator (non-CRT)
Decision date: 2016-03-03
Decision code: APPR
Date received: 2016-01-20
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for updates to the Physician’s Technical Manuals (PTMs) for ICDs and CRT-Ds