- Device
- ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI Pacemakers
- Applicant
- Boston Scientific
- PMA number
- P150012
- Supplement
- S100
- Product code
- LWP
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Decision date
- 2020-10-16
- Decision code
- APPR
- Date received
- 2020-08-13
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval to allow an additional mold release/de-nest agent to be applied to the polyethylene terephthalate glycol (PETG) sheets used to form sterile packaging.