PMA P010012S473
- Device
- NG3 Family of CRT-Ds (Autogen, Dynagen, Inogen, Origen) / NG4 Family of CRT-Ds (Resonate, Vigilant)
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S473
- Product code
- NIK
- Decision date
- 2018-02-02
- Classification
- Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Approval order statement
- Approval for labeling updates to the pulse generator replacement guide.
Current openFDA PMA Record#
- Device
- NG3 Family of CRT-Ds (Autogen, Dynagen, Inogen, Origen) / NG4 Family of CRT-Ds (Resonate, Vigilant)
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S473
- Product code
- NIK
- Generic name
- Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
- Decision date
- 2018-02-02
- Decision code
- APPR
- Date received
- 2017-12-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for labeling updates to the pulse generator replacement guide.