Ingevity, Ingevity MRI
FDA premarket approval P150012/S064 · decided 2018-07-26
Approval details
- PMA number
- P150012
- Supplement
- S064
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Ingevity, Ingevity MRI
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2018-07-13
- Decision date
- 2018-07-26
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Implement the Central Monitoring System for the monitoring of environmental conditions at the Dorado facility.
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