ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI
FDA premarket approval P150012/S112 · decided 2021-09-03
Approval details
- PMA number
- P150012
- Supplement
- S112
- 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
- 2021-06-11
- Decision date
- 2021-09-03
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the addition of Platinum/Iridium feedthru wires as an alternate to the Palladium/Iridium feedthru wires used in the Filtered Feedthru Assembly and minor design changes updating the extended life battery stack insulator.
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