ESSENTIO MRI SR SL (L110); ESSENTIO MRI DR SL (L111); ESSENTIO MRI DR EL (L131); PROPONENT MRI SR SL (L210); PROPONE
FDA premarket approval P150012/S189 · decided 2026-07-23
Approval details
- PMA number
- P150012
- Supplement
- S189
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ESSENTIO MRI SR SL (L110); ESSENTIO MRI DR SL (L111); ESSENTIO MRI DR EL (L131); PROPONENT MRI SR SL (L210); PROPONE
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2026-06-26
- Decision date
- 2026-07-23
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- to add a functionally equivalent alternate vapor degreasing solvent used to remove contaminants from pulse generator components
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