PMA P960040S385
- Device
- NG4 Family of Pulse Generators ICDS.
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S385
- Product code
- LWS
- Decision date
- 2017-05-02
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Approval for NG4 models of ICD and CRT-D devices with new therapy and diagnostic features.
Current openFDA PMA Record#
- Device
- NG4 Family of Pulse Generators ICDS.
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S385
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-05-02
- Decision code
- APPR
- Date received
- 2016-10-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for NG4 models of ICD and CRT-D devices with new therapy and diagnostic features.