PMA P960040S412
- Device
- Autogen, Dynagen, Energen, Incepta, Inogen, Momentum, Origen, Perciva, Punctua, Resonate, Vigiliant, Vitality ICDs
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S412
- Product code
- LWS
- Decision date
- 2017-12-19
- Classification
- Implantable Cardioverter Defibrillator (non-crt)
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Approval order statement
- Change in the bacterial endotoxin test sampling plan and frequency.
Current openFDA PMA Record#
- Device
- Autogen, Dynagen, Energen, Incepta, Inogen, Momentum, Origen, Perciva, Punctua, Resonate, Vigiliant, Vitality ICDs
- Applicant
- Boston Scientific
- PMA number
- P960040
- Supplement
- S412
- Product code
- LWS
- Generic name
- Implantable cardioverter defibrillator (non-CRT)
- Decision date
- 2017-12-19
- Decision code
- OK30
- Date received
- 2017-11-21
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Change in the bacterial endotoxin test sampling plan and frequency.