PMA P960040S420
- Device
- NG3 Implantable Cardioverter Defibrillators - Origen, Inogen, Dynagen, Autogen / NG4 - Momentum, Vigilant, Resonate, Per
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S420
- Product code
- LWS
- Decision date
- 2018-02-21
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Modify the taping process for capacitors by adding a new equipment.
Current openFDA PMA Record#
- Device
- NG3 Implantable Cardioverter Defibrillators - Origen, Inogen, Dynagen, Autogen / NG4 - Momentum, Vigilant, Resonate, Per
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S420
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2018-02-21
- Decision code
- OK30
- Date received
- 2018-02-02
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the taping process for capacitors by adding a new equipment.