PMA P960040S409
- Device
- Autogen, Dynagen, Inogen, Origen (NG3 ICDs), Momentum, Vigilant, Perciva, Resonate (NG4 ICDs)
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S409
- Product code
- LWS
- Decision date
- 2017-12-01
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Upgrade device header overmolding equipment.
Current openFDA PMA Record#
- Device
- Autogen, Dynagen, Inogen, Origen (NG3 ICDs), Momentum, Vigilant, Perciva, Resonate (NG4 ICDs)
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S409
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-12-01
- Decision code
- OK30
- Date received
- 2017-11-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Upgrade device header overmolding equipment.