Esprit BTK Everolimus Eluting Resorbable Scaffold System
FDA premarket approval P230036/S006 · decided 2024-08-28
Approval details
- PMA number
- P230036
- Supplement
- S006
- 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
- 2024-08-01
- Decision date
- 2024-08-28
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- NXW
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- a change to the sampling plan for finished device in vitro engineering lot release and analytical lot release testing
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