Device, Hemostasis, Vascular
Basic Information
- Device Name
- Device, Hemostasis, Vascular
- Trade Name
- STARCLOSE AND STARCLOSE SE VASCULAR CLOSURE SYSTEMS
- PMA Number
- P050007
- Supplement Number
- S009
- 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 25, 2008
- Date Received
- March 31, 2008
- Supplement Type
- Normal 180 Day Track
- Supplement Reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR MODIFICATIONS TO THE INDICATIONS FOR USE. THE DEVICE, AS MODIFIED, WILL BE INDICATED FOR THE FOLLOWING: THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS, AMBULATION, AND DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH. THE STARCLOSE VASCULAR CLOSURE SYSTEM IS INDICATED FOR USE TO ALLOW PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES TO AMBULATE AND BE ELIGIBLE FOR DISCHARGE AS SOON AS POSSIBLE AFTER DEVICE PLACEMENT. THE STARCLOSE VASCULAR CLOSURE SYSTEM IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION, IN PATIENTS WHO HAVE UNDERGONE INTERVENTIONAL ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH.
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 |