ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI
FDA premarket approval P150012/S185 · decided 2026-06-03
Approval details
- PMA number
- P150012
- Supplement
- S185
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ESSENTIO MRI, PROPONENT MRI, ACCOLADE MRI
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2026-05-04
- Decision date
- 2026-06-03
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- to implement a new process monitor for feedthrough sputter thickness and add the associated design output specification for pulse generator devices
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