CELT ACD Vascular Closure Device
FDA premarket approval P150006/S004 · decided 2019-08-26
Approval details
- PMA number
- P150006
- Supplement
- S004
- 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
- 2019-08-13
- Decision date
- 2019-08-26
- Days to decision
- 13 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Dublin
- Statement
- Expanded e-beam sterilization dose range.
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