ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM
FDA premarket approval P930038/S035 · decided 2002-12-20
Approval details
- PMA number
- P930038
- Supplement
- S035
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ANGIO-SEAL VASCULAR CLOSURE DEVICE STS PLUS PLATFORM
- Generic name
- Device, hemostasis, vascular
- Applicant
- Terumo Medical Corporation
- Date received
- 2002-11-20
- Decision date
- 2002-12-20
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Elkton, MD
- Statement
- APPROVAL FOR MODIFICATIONS TO THE INSERTION SHEATH (ADDITION OF PUNCTURE HOLES), GUIDEWIRE (INCREASE GUIDEWIRE SIZE FOR THE 6FR. DEVICE), PUNCTURE LOCATOR (MOVE LOCATOR HOLES, LABEL LOCATION (MOVE TO OUTSIDE OF PACKAGE) AND THE INSTRUCTIONS FOR USE (REVISE LABELING TO INCLUDE NEW INSTRUCTIONS RELATED TO THESE DESIGN CHANGES).
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