ESSENTIO MRI SR; ESSENTIO MRI DR; ESSENTIO MRI EL DR; PROPONENT MRI SR ; PROPONENT MRI DR; PROPONENT MRI EL DR; ACCOLA
FDA premarket approval P150012/S119 · decided 2021-10-21
Approval details
- PMA number
- P150012
- Supplement
- S119
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ESSENTIO MRI SR; ESSENTIO MRI DR; ESSENTIO MRI EL DR; PROPONENT MRI SR ; PROPONENT MRI DR; PROPONENT MRI EL DR; ACCOLA
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2021-10-08
- Decision date
- 2021-10-21
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Automate a battery component cleaning process.
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