PMA P960040S407
- Device
- Autogen, Dynagen, Inogen,Origen / NG3 Implantable Cardiac Defibrillators / Momentur, Vigilant, Perciva, Resonate / NG4 I
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S407
- Product code
- LWS
- Decision date
- 2017-10-26
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Addition of a dual illumination source solder print inspection system.
Current openFDA PMA Record#
- Device
- Autogen, Dynagen, Inogen,Origen / NG3 Implantable Cardiac Defibrillators / Momentur, Vigilant, Perciva, Resonate / NG4 I
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S407
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-10-26
- Decision code
- OK30
- Date received
- 2017-09-28
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Addition of a dual illumination source solder print inspection system.