Esprit BTK Everolimus Eluting Resorbable Scaffold System
FDA premarket approval P230036/S015 · decided 2025-09-26
Approval details
- PMA number
- P230036
- Supplement
- S015
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Esprit BTK Everolimus Eluting Resorbable Scaffold System
- Generic name
- Scaffold, infrapopliteal, absorbable
- Applicant
- ABBOTT MEDICAL
- Date received
- 2025-08-29
- Decision date
- 2025-09-26
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- NXW
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- to update the endotoxin sampling quantity and testing frequency
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