DUETT PRO SEALING DEVICE AND THE DIAGNOSTIC DUETT PRO SEALING DEVICE SEALING DEVICE
FDA premarket approval P990037/S012 · decided 2003-01-30
Approval details
- PMA number
- P990037
- Supplement
- S012
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DUETT PRO SEALING DEVICE AND THE DIAGNOSTIC DUETT PRO SEALING DEVICE SEALING DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Vascular Solutions, Inc.
- Date received
- 2003-01-17
- Decision date
- 2003-01-30
- Days to decision
- 13 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 PRO SEALING DEVICE AND THE DIAGNOSTIC DUETT PRO SEALING DEVICE. SPECIFICALLY, 1) REMOVAL OF THE SILICONE GASKET FROM THE PRESSURE RELIEF VALVE DESIGN; 2) REMOVAL OF A LUER LOCK THREAD/ATTACHMENT WHICH WAS USED TO CONNECT THE CATHETER TO THE PRESSURE RELIEF VALVE AND REPLACE WITH AN ADHESIVE BOND; 3) REMOVAL OF THE CAP COVER AND THREADS FROM THE RELIEF VALVE, AND 4) SHORTENING OF THE LENGTH AND HEIGHT OF THE RELIEF VALVE.
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