Device, Hemostasis, Vascular
Basic Information
- Device Name
- Device, Hemostasis, Vascular
- Trade Name
- VASOSEAL ELITE VHD/ES DEVICE
- PMA Number
- P920004
- Supplement Number
- S018
- Device Class
- FDA Class 3
- Product Code
- MGB
- Generic Name
- Device, hemostasis, vascular
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 13, 2002
- Date Received
- March 26, 2002
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR THE USE OF A SINGLE SPONGE COLLAGEN PLUG. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES VASOSEAL ELITE VHD OR ES DEVICE AND IS INDICATED FOR: "SEALING THE FEMORAL ARTERIAL PUNCTURE SITE IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES USING AN 8 FRENCH OR SMALLER PROCEDURAL SHEATH AND USING A RETROGRADE APPROACH. THE VASOSEAL ELITE VHD/ES DEVICE REDUCES TIME TO HEMOSTASIS, AND AMBULATION IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC AND INTERVENTIONAL CATHETERIZATION PROCEDURES. IN ADDITION, THE VASOSEAL ELITE VHD/ES DEVICE REDUCES TIME TO DISCHARGE IN DIAGNOSTIC PATIENTS RECEIVING 5-6 FRENCH PROCEDURAL SHEATHS. VASOSEAL ELITE VHD/ES DEVICE REDUCES TIME TO HEMOSTASIS IN INTERVENTIONAL, PATIENTS, WHEN IMMEDIATE SHEATH REMOVAL IS DESIRED." THE VASOSEAL ELITE VHD DEVICE INDICATIONS INCLUDE THE STATEMENT: "HOWEVER, EARLY AMBULATION IN THESE PATIENTS HAS NOT BEEN DETERMINED."
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MGB | Device, Hemostasis, Vascular | FDA class 3 | Unknown |