INGEVITY MRI Endocardial Steroid-eluting MR Conditional Stylet delivered Pace/Sense Lead, INGEVITY+ Pace/Sense Lead
FDA premarket approval P150012/S146 · decided 2023-06-29
Approval details
- PMA number
- P150012
- Supplement
- S146
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- INGEVITY MRI Endocardial Steroid-eluting MR Conditional Stylet delivered Pace/Sense Lead, INGEVITY+ Pace/Sense Lead
- Generic name
- Implantable pulse generator, pacemaker (non-CRT)
- Applicant
- Boston Scientific
- Date received
- 2023-06-09
- Decision date
- 2023-06-29
- Days to decision
- 20 days
- Decision code
- OK30
- Product code
- LWP
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- St Paul, MN
- Statement
- Changes to J-Tip stylet forming equipment, method and associated processes.
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