ESSENTIO MRI SR, ESSENTIO MRI DR, ESSENTIO MRI EL DR, PROPONENT MRI SR, PROPONENT MRI DR, PROPONENT MRI EL DR, ACCOLAD
FDA premarket approval P150012/S130 · decided 2022-09-27
Approval details
- PMA number
- P150012
- Supplement
- S130
- 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, ACCOLAD
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2022-09-20
- Decision date
- 2022-09-27
- Days to decision
- 7 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Implement an automatic handling system for the helium leak test process.
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