Ingevity MRI Leads and Slit Suture Sleeve Accessory for Ingevity Leads
FDA premarket approval P150012/S078 · decided 2019-07-31
Approval details
- PMA number
- P150012
- Supplement
- S078
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Ingevity MRI Leads and Slit Suture Sleeve Accessory for Ingevity Leads
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2019-05-03
- Decision date
- 2019-07-31
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- approval for enhancements and modifications to existing market released products including hardware, MRI labeling and manufacturing changes as well as software updates
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