INGEVITY MRI, INGEVITY+
FDA premarket approval P150012/S139 · decided 2023-04-19
Approval details
- PMA number
- P150012
- Supplement
- S139
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- INGEVITY MRI, INGEVITY+
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2023-01-19
- Decision date
- 2023-04-19
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Approval for the replacement of raw material Elasthane 55D MR supplied by DSM with Pellethane 2363 55D supplied by Lubrizol Advanced Materials, Inc for use in the polyurethane outer insulation tubing for the INGEVITY MRI and INGEVITY+ leads.
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