VASCULAR SOLUTIONS DUETT SEALING DEVICE
FDA premarket approval P990037/S009 · decided 2002-04-03
Approval details
- PMA number
- P990037
- Supplement
- S009
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VASCULAR SOLUTIONS DUETT SEALING DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Vascular Solutions, Inc.
- Date received
- 2002-03-15
- Decision date
- 2002-04-03
- Days to decision
- 19 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR A DESIGN CHANGE TO THE DUETT SEALING DEVICE AND DIAGNOSTIC DUETT SEALING DEVICE. SPECIFICALLY, A RELIEF VALVE COMPONENT WILL REPLACE THE PILOT BALLOON ASSEMBLY ON BOTH DEVICES.
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