CELT ACD VASCULAR CLOSURE DEVICE
FDA premarket approval P150006/S001 · decided 2017-06-27
Approval details
- PMA number
- P150006
- Supplement
- S001
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- CELT ACD VASCULAR CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Vasorum, Ltd.
- Date received
- 2016-10-17
- Decision date
- 2017-06-27
- Days to decision
- 253 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Dublin
- Statement
- Approval for the addition of a 7F size CELT ACD Vascular Closure Device and minor manufacturing and design changes to the 5F, 6F, and 7F CELT ACD Vascular Closure Devices.
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