PMA P150012S046
- Device
- Accolade MRI Pacemakers: ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S046
- Product code
- LWP
- Decision date
- 2017-12-11
- Classification
- Implantable Pulse Generator, Pacemaker (non-crt)
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Approval order statement
- Modifications to a suppliers cleaning process used in the manufacture of the MICS module component of the pulse generators hybrid.
Current openFDA PMA Record#
- Device
- Accolade MRI Pacemakers: ESSENTIO MRI, PROPONENT MRI and ACCOLADE MRI
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S046
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2017-12-11
- Decision code
- OK30
- Date received
- 2017-11-13
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Modifications to a suppliers cleaning process used in the manufacture of the MICS module component of the pulse generators hybrid.