PMA P150012S050
- Device
- Accolade MRI, Essentio MRI, Formio MRI, Ingenio MRI, Proponent MRI, Vitalio MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S050
- Product code
- LWP
- Decision date
- 2017-12-19
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Change in the bacterial endotoxin test sampling plan and frequency.
Current openFDA PMA Record#
- Device
- Accolade MRI, Essentio MRI, Formio MRI, Ingenio MRI, Proponent MRI, Vitalio MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S050
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (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.