PMA P960040S414
- Device
- NG3 Family of ICDs (Autogen, Dynagen, Inogen and Origen) NG4 Family of ICDs (Resonate, Vigilant and Perciva)
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S414
- Product code
- LWS
- Decision date
- 2018-02-02
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for labeling updates to the pulse generator replacement guide.
Current openFDA PMA Record#
- Device
- NG3 Family of ICDs (Autogen, Dynagen, Inogen and Origen) NG4 Family of ICDs (Resonate, Vigilant and Perciva)
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S414
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- 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.