CELT ACD Vascular Closure Device
FDA premarket approval P150006/S007 · decided 2025-12-18
Approval details
- PMA number
- P150006
- Supplement
- S007
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- CELT ACD Vascular Closure Device
- Generic name
- Device, hemostasis, vascular
- Applicant
- Vasorum, Ltd.
- Date received
- 2025-12-05
- Decision date
- 2025-12-18
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Dublin
- Statement
- a new adhesive to be used in the Tyvek packaging lid
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