Esprit BTK Everolimus Eluting Resorbable Scaffold System
FDA premarket approval P230036/S007 · decided 2024-12-11
Approval details
- PMA number
- P230036
- Supplement
- S007
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Esprit BTK Everolimus Eluting Resorbable Scaffold System
- Generic name
- Scaffold, infrapopliteal, absorbable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2024-08-19
- Decision date
- 2024-12-11
- Days to decision
- 114 days
- Decision code
- APPR
- Product code
- NXW
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- to qualify Sterigenics Radiation Technologies, LLC, San Diego (Sterigenics SD) as an alternative sterilization site
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