PMA P150012S048
- Device
- ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI, MRI Pacemakers
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S048
- Product code
- LWP
- Decision date
- 2017-12-06
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Additional electrolyte supplier for pulse generator batteries, an approved manufacturing location for the existing battery electrolyte supplier, and updates to associated acceptance activities.
Current openFDA PMA Record#
- Device
- ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI, MRI Pacemakers
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S048
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2017-12-06
- Decision code
- OK30
- Date received
- 2017-11-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Additional electrolyte supplier for pulse generator batteries, an approved manufacturing location for the existing battery electrolyte supplier, and updates to associated acceptance activities.