ESSENTIO MRI / PROPONENT MRI / ACCOLADE MRI
FDA premarket approval P150012/S034 · decided 2017-09-21
Approval details
- PMA number
- P150012
- Supplement
- S034
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ESSENTIO MRI / PROPONENT MRI / ACCOLADE MRI
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2017-07-24
- Decision date
- 2017-09-21
- Days to decision
- 59 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.