ANGIO-SEAL VASCULAR CLOSURE DEVICE
FDA premarket approval P930038/S043 · decided 2005-05-12
Approval details
- PMA number
- P930038
- Supplement
- S043
- Supplement type
- Real-Time Process
- 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
- 2005-02-08
- Decision date
- 2005-05-12
- Days to decision
- 93 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Elkton, MD
- Statement
- APPROVAL FOR CHANGING THE LOT RELEASE SAMPLING PLAN AND PERFORMANCE SPECIFICATION.
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