PMA P960040S399
- Device
- NG3 Implantable Cardiac Defibrillators, Autogen, Dynagen, Inogen, Origen ICD's; NG4 ICDs- Momentum, Vigilant, Perciva,Re
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S399
- Product code
- LWS
- Decision date
- 2017-08-30
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Modify test software used in the wafer fabrication process.
Current openFDA PMA Record#
- Device
- NG3 Implantable Cardiac Defibrillators, Autogen, Dynagen, Inogen, Origen ICD's; NG4 ICDs- Momentum, Vigilant, Perciva,Re
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S399
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-08-30
- Decision code
- OK30
- Date received
- 2017-08-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify test software used in the wafer fabrication process.