DUETT PRO SEALING DEVICE AND DIAGNOSTIC DUETT PRO SEALING DEVICE
FDA premarket approval P990037/S021 · decided 2004-07-14
Approval details
- PMA number
- P990037
- Supplement
- S021
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- DUETT PRO SEALING DEVICE AND DIAGNOSTIC DUETT PRO SEALING DEVICE
- Generic name
- Device, hemostasis, vascular
- Applicant
- Vascular Solutions, Inc.
- Date received
- 2004-06-15
- Decision date
- 2004-07-14
- Days to decision
- 29 days
- Decision code
- APPR
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- APPROVAL FOR MODIFYING THE PRESSURE RELIEF VALVE COMPONENT ON THE CATHETER AND REPLACING THE MIXING 20 GAUGE NEEDLE SYRINGE WITH A NEEDLELESS NON-CORING VIAL ACCESS DEVICE.
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