INGENIO 2 MRI PACEMAKERS.
FDA premarket approval P150012/S004 · decided 2016-07-14
Approval details
- PMA number
- P150012
- Supplement
- S004
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INGENIO 2 MRI PACEMAKERS.
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2016-05-06
- Decision date
- 2016-07-14
- Days to decision
- 69 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for design changes to the accelerometer component and associated changes.
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