CELT ACD VASCULAR CLOSURE DEVICE
FDA premarket approval P150006 · decided 2016-07-20
Approval details
- PMA number
- P150006
- Trade name
- CELT ACD VASCULAR CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Vasorum, Ltd.
- Date received
- 2015-02-03
- Decision date
- 2016-07-20
- Days to decision
- 533 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Dublin
- Statement
- Approval for the Celt ACD Vascular Closure Device. This device is indicated for the percutaneous closure of common femoral artery puncture sites while reducing time-to-hemostasis in patients who have undergone diagnostic or interventional intra-arterial catheterization procedures where either 5F or 6F introducer sheaths have been used.
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