ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI
FDA premarket approval P150012/S103 · decided 2020-11-16
Approval details
- PMA number
- P150012
- Supplement
- S103
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- ESSENTIO MRI, PROPONENT MRI, and ACCOLADE MRI
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2020-10-21
- Decision date
- 2020-11-16
- Days to decision
- 26 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Implement a new manufacturing process for the front desiccant/liner components and remove a supplier of low voltage capacitors.
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