PMA P150012S037
- Device
- Pacemakers: Ingenio MRI, Vitalio MRI, Formio MRI, Essentio MRI, Proponent MRI, and Accolade MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S037
- Product code
- LWP
- Decision date
- 2017-09-25
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Modify the quartz crystal component manufacturing process.
Current openFDA PMA Record#
- Device
- Pacemakers: Ingenio MRI, Vitalio MRI, Formio MRI, Essentio MRI, Proponent MRI, and Accolade MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S037
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2017-09-25
- Decision code
- OK30
- Date received
- 2017-09-05
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modify the quartz crystal component manufacturing process.