CELT ACD PLUS Vascular Closure Device
FDA premarket approval P150006/S006 · decided 2025-01-24
Approval details
- PMA number
- P150006
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CELT ACD PLUS Vascular Closure Device
- Generic name
- Device, hemostasis, vascular
- Applicant
- Vasorum, Ltd.
- Date received
- 2024-10-23
- Decision date
- 2025-01-24
- Days to decision
- 93 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Dublin
- Statement
- approval for a CELT ACD PLUS device which included a blood signal indicator
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