ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS
FDA premarket approval P930038/S041 · decided 2004-11-04
Approval details
- PMA number
- P930038
- Supplement
- S041
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS
- Generic name
- Device, hemostasis, vascular
- Applicant
- Terumo Medical Corporation
- Date received
- 2004-10-21
- Decision date
- 2004-11-04
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Elkton, MD
- Statement
- APPROVAL FOR A NEW ANCHOR DESIGN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIOSEAL VASCULAR CLOSURE DEVICE STS PLUS.
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