PMA P010012S399
- Device
- DYNAGEN CRT-D, DYNAGEN X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, ORIGEN CRT-D, ORIGEN X4 CRT-D
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S399
- Product code
- LWS
- Decision date
- 2015-10-02
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- APPROVAL FOR DESIGN CHANGES TO THE NG3 AND NG2.5 HIGH VOLTAGE CAPACITORS FOR THE DEVICES.
Current openFDA PMA Record#
- Device
- DYNAGEN CRT-D, DYNAGEN X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, ORIGEN CRT-D, ORIGEN X4 CRT-D
- Applicant
- Boston Scientific Corp
- PMA number
- P010012
- Supplement
- S399
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2015-10-02
- Decision code
- APPR
- Date received
- 2015-09-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR DESIGN CHANGES TO THE NG3 AND NG2.5 HIGH VOLTAGE CAPACITORS FOR THE DEVICES.