CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR, NG3 CRT-D DYNAGEN CRT-D & X4 CRT-D, INOGEN CRT-D & X4 CRT-D. ORIGEN CRT
FDA premarket approval P010012/S409 · decided 2016-03-03
Approval details
- PMA number
- P010012
- Supplement
- S409
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR, NG3 CRT-D DYNAGEN CRT-D & X4 CRT-D, INOGEN CRT-D & X4 CRT-D. ORIGEN CRT
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Applicant
- Boston Scientific Corp
- Date received
- 2016-01-20
- Decision date
- 2016-03-03
- Days to decision
- 43 days
- Decision code
- APPR
- Product code
- LWS
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for updates to the Physicians Technical Manuals (PTMs) for ICDs and CRT-Ds
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