Ingevity MRI
FDA premarket approval P150012/S070 · decided 2019-02-28
Approval details
- PMA number
- P150012
- Supplement
- S070
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Ingevity MRI
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2018-12-26
- Decision date
- 2019-02-28
- Days to decision
- 64 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the sales packaging and label changes being made to BSC lead families
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