ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS, MODELS 610130 AND 610131
FDA premarket approval P930038/S040 · decided 2004-09-13
Approval details
- PMA number
- P930038
- Supplement
- S040
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS, MODELS 610130 AND 610131
- Generic name
- Device, hemostasis, vascular
- Applicant
- Terumo Medical Corporation
- Date received
- 2004-08-23
- Decision date
- 2004-09-13
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Elkton, MD
- Statement
- APPROVAL FOR A NEW 9 HOLE, HOUR-GLASS SHAPE COLLAGEN SPONGE AND A COATED SUTURE WITH MINOR CHANGES TO THE CARRIER TUBE TO INCORPORATE THE COLLAGEN SPONGE CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS, MODELS 610130 (6 FR.) AND 610131 (8 FR.).
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