ANGIO-SEAL VASCULAR CLOSURE DEVICE
FDA premarket approval P930038/S046 · decided 2006-10-05
Approval details
- PMA number
- P930038
- Supplement
- S046
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ANGIO-SEAL VASCULAR CLOSURE DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Terumo Medical Corporation
- Date received
- 2005-10-12
- Decision date
- 2006-10-05
- Days to decision
- 358 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Elkton, MD
- Statement
- APPROVAL TO REMOVE THE CURRENT PRECAUTION PERTAINING TO PATIENTS WITH PERIPHERAL VASCULAR DISEASE (PVD) FROM THE SPECIAL PATIENT POPULATIONS SECTION AND ADD A PRECAUTION TO TE PROCEDURE SECTION, IDENTIFYING PUBLISHED CLINICAL EXPERIENCE OF PATIENTS WITH PVD.
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